'calibration services'

What are the aims and objectives of NABL…? National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide government, industry and society in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. Government of India has authorized NABL as the sole accreditation body for testing and calibration laboratories. In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with NABL criteria based on internationally accepted standard for laboratory accreditation ISO/IEC 17025. These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad, regardless of their ownership, legal status, size and degree of independence. What Is Laboratory Accreditation? The concept of Laboratory Accreditation was developed to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing and calibration. Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands. Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories. The globalization of Indian economy and the liberalization policies initiated by the government in reducing trade barriers and providing greater thrust to exports that makes it imperative for accredited laboratories to be at international level of competence. What Are Benefits Of Accreditation? Potential increase in business due to enhanced customer confidence and satisfaction. Savings in terms of time and money due to reduction or elimination of the need for re-testing of products. Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent. Increase of confidence in Testing / Calibration data and personnel performing work. Customers can search and identify the laboratories accredited by NABL for their specific requirements from the directory of accredited laboratories. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories. What types of laboratories can seek accreditation…? The laboratories should be legally identifiable & appropriately registered. They can be a part of a big organization or an independent entity. NABL can provide accreditation to: Laboratories undertaking any sort of testing or calibration in the specified fields, private or government laboratories, small operations to large multi-field laboratories, site facilities, temporary field operations and mobile laboratories.

FSSC 22000 v6 Certification Food Safety Compliance Made Easy with Shark Certification Pvt. Ltd., Indore In today’s global food market, food safety is not just a requirement—it’s a responsibility. The FSSC 22000 Version 6 Certification is a globally recognized food safety standard that combines ISO-based systems with specific sector requirements to help organizations ensure food safety across the supply chain. At Shark Certification Pvt. Ltd., we provide expert guidance and end-to-end support to help your business in Indore and across India achieve FSSC 22000 v6 Certification smoothly and efficiently. 🌐 What is FSSC 22000 v6? FSSC 22000 (Food Safety System Certification) is a robust, ISO-based food safety management system recognized by the Global Food Safety Initiative (GFSI). Version 6 brings new and enhanced requirements, focusing on risk management, food fraud prevention, and sustainability. It is applicable to organizations across the entire food supply chain, including: Food manufacturers Animal feed producers Packaging material manufacturers Catering and food service providers Retailers and wholesalers Logistics and transportation companies 🔍 What’s New in FSSC 22000 Version 6? Enhanced focus on food safety culture Updated requirements for equipment management Stronger control of allergens Greater emphasis on environmental monitoring and validation Clearer definitions for food fraud and food defense programs Our team stays up to date with every change in the standard so you don’t have to worry about what’s new—we guide you every step of the way. 🛠️ Our FSSC 22000 v6 Certification Services At Shark Certification Pvt. Ltd., we offer complete support for companies seeking FSSC 22000 certification: ✅ Gap Assessment & Readiness Check We begin with a full review of your current systems and identify areas needing improvement to meet FSSC 22000 v6 requirements. ✅ Implementation Support Our team helps design and implement a food safety management system (FSMS) tailored to your business, ensuring compliance with all key clauses of FSSC 22000 v6. ✅ Internal Audit & Pre-Certification Checks We conduct detailed audits to prepare your team for the final certification. This includes food defense, food fraud, traceability, risk control, and GMP reviews. ✅ Training for Staff & Management Customized training programs are provided to improve awareness and ensure team readiness—from floor workers to top management. ✅ Support During Certification Audit We assist in coordinating with certification bodies, handling documentation, and providing on-site support during your audit. 🎯 Why Choose Shark Certification Pvt. Ltd. in Indore? 🏢 Local presence, global reach – Based in Indore, we support clients throughout India 👨‍💼 Experienced consultants & auditors – Deep knowledge of FSSC, ISO, and GFSI frameworks 🧩 Custom solutions – Whether you’re a small processor or a large manufacturer, we tailor our approach to your business 💼 End-to-end service – From documentation to audit closure 💡 Up-to-date with Version 6 – Fully aligned with the latest version of FSSC 22000 standard 📞 Let’s Get Started Today! Become FSSC 22000 v6 certified with confidence and unlock global opportunities in food production and export.

EU Deforestation Regulation (EUDR) Consulting Services By Shark Certification Pvt. Ltd., Indore – Guiding You Toward Responsible Sourcing and Regulatory Compliance The European Union Deforestation Regulation (EUDR) is a game-changing directive that affects a wide range of industries sourcing commodities linked to deforestation. At Shark Certification Pvt. Ltd., we offer expert consulting services to help businesses across India and beyond understand, comply with, and implement EUDR requirements effectively. 🌍 What is the EUDR? The EUDR aims to eliminate deforestation from supply chains by requiring businesses to ensure that their imported or exported products are not linked to illegal deforestation or forest degradation. This regulation applies to commodities like soy, cocoa, palm oil, coffee, cattle, timber, and rubber—and extends to derived products such as leather, paper, and furniture. If your company trades with the EU or supplies to EU-based partners, EUDR compliance is not optional—it's essential. 🛠️ Our EUDR Consulting Services Shark Certification Pvt. Ltd. offers complete support for businesses affected by the EUDR. Our services are built around clarity, compliance, and sustainable growth: ✅ 1. EUDR Impact & Compliance Assessment We analyze your supply chain and business processes to evaluate how EUDR applies to your operations. Our assessment covers: Product origins and sourcing practices Supply chain traceability gaps Legal and compliance risks Documentation readiness ✅ 2. Strategy & Implementation Support We guide your organization in aligning with the EUDR through tailored implementation plans, including: Building traceability and tracking systems Revising procurement and supplier policies Supplier onboarding and risk evaluation ✅ 3. Due Diligence & Risk Mitigation The EUDR mandates strong due diligence mechanisms. We help you: Conduct risk assessments for high-risk supply chains Develop mitigation strategies Monitor ongoing compliance ✅ 4. Staff Training & Capacity Building Our specialized training modules help teams across departments understand: EUDR regulatory expectations Risk identification and documentation Day-to-day roles in maintaining compliance ✅ 5. Reporting & Documentation Support We assist in organizing and managing documentation needed to demonstrate compliance, including: Due diligence statements Supplier declarations Verification records for product origins and legality 🤝 Why Partner with Shark Certification Pvt. Ltd.? ✔️ Expertise in Global Sustainability Regulations ✔️ India-based, globally aligned consulting ✔️ Customized solutions for SMEs and large enterprises ✔️ Efficient implementation and audit readiness ✔️ Ongoing compliance support We work closely with manufacturers, exporters, importers, and suppliers to help them meet the requirements of the EUDR and remain competitive in environmentally conscious markets.

Promoting Responsible Soy Cultivation with RTRS Certification By Shark Certification Pvt. Ltd., Indore At Shark Certification Pvt. Ltd., we are committed to advancing responsible agricultural practices through globally recognized certifications. Our RTRS (Round Table on Responsible Soy) Certification services are designed to support soy and corn producers, processors, and supply chain partners in aligning with sustainable and ethical production standards. What is RTRS Certification? The RTRS Certification is an international standard promoting environmentally sound, socially responsible, and economically viable soy production. It is a voluntary initiative that brings together stakeholders from across the soy and corn value chains to ensure sustainability, respect for local communities, and protection of ecosystems. RTRS also meets the sustainability criteria of the European Renewable Energy Directive, adding further value for companies operating globally. Key Objectives of RTRS Encourage sustainable and responsible soy production and trade practices Support inclusive decision-making through stakeholder engagement Promote biodiversity conservation and environmental protection Uphold labor rights and respect for local land ownership Ensure economic viability and positive impact on local communities Benefits of RTRS Certification for Your Business Strengthened Supply Chain Credibility: Show your stakeholders that your soy products come from responsible and traceable sources Access to Global Markets: Align with international sustainability standards and meet the expectations of environmentally conscious consumers Support for Sustainable Development: Help reduce deforestation and encourage economic growth in soy-producing regions Compliance with International Regulations: Meet the sustainability criteria of key regulatory frameworks such as the EU Renewable Energy Directive RTRS Production Standard Highlights The RTRS Production Standard covers a wide range of criteria to ensure ethical and sustainable soy cultivation. Key focus areas include: Protection of biodiversity and high conservation value areas Soil health and responsible pesticide use Water management and preservation Fair treatment of workers and respect for indigenous communities Responsible land use and legal land ownership Improvement of local infrastructure and community well-being Who Can Get Certified? RTRS Certification is open to: Small and large-scale soy producers Processing and trading companies in the soy supply chain Organizations using soy in food, feed, and biofuel products Smaller producers can benefit from group certification models, which make the process more cost-effective and accessible. How to Become RTRS Certified with Shark Certification Pvt. Ltd. Shark Certification Pvt. Ltd. offers end-to-end support for RTRS certification, from preparation to final audit. The process includes: Initial Consultation – Understanding your business needs and identifying the applicable RTRS standards Pre-Audit Readiness Check – Helping your team align documentation and practices with RTRS criteria Stakeholder Consultation – A two-week public consultation phase before the main audit On-Site Audit – Conducted by our trained and accredited auditors Certification Decision – Based on full compliance with RTRS standards Why Choose Shark Certification Pvt. Ltd.? Based in Indore, Shark Certification Pvt. Ltd. brings a strong reputation for transparent, credible, and globally aligned certification services. With deep industry knowledge and experience in sustainable agriculture, we are the right partner to guide your organization toward RTRS compliance. Our expert auditors are trained in various sustainability frameworks, making it easy for you to combine RTRS with other certifications such as: ProTerra Certification ISCC PLUS & EU Bonsucro & RSPO Food Safety & Non-GMO Compliance Programs Take the Lead in Sustainable Soy Production Becoming RTRS certified is more than a certification—it's a commitment to a better future for the planet and its people. Whether you're a producer, processor, or trader, Shark Certification Pvt. Ltd. is here to help you demonstrate your values, build consumer trust, and meet global sustainability expectations. Reach out today to start your RTRS certification journey with Shark Certification Pvt. Ltd., your trusted sustainability partner in Indore.

Promoting Sustainable, Traceable, and Non-GMO Agriculture with ProTerra Certification By Shark Certification Pvt. Ltd., Indore At Shark Certification Pvt. Ltd., we are proud to offer ProTerra Certification, a globally respected standard for sustainable, non-GMO agriculture and food systems. Designed to ensure transparency, traceability, and ethical practices across the entire supply chain, ProTerra Certification helps organizations demonstrate their commitment to responsible production and environmental stewardship. What is ProTerra Certification? ProTerra is a comprehensive sustainability standard focused on promoting responsible agricultural practices, protection of natural resources, and the exclusion of genetically modified organisms (GMOs). It supports traceability and accountability at every stage—from farms to processing facilities and trading entities—helping companies meet growing consumer and regulatory demands for sustainability. Three Levels of Certification Offered Depending on your role in the supply chain, Shark Certification Pvt. Ltd. can assist with the appropriate level of certification: Level I – Agricultural Production: For farms and growers, this includes the entire production area, encompassing both cultivated and non-cultivated zones. Level II – Storage, Transport & Trading: Focused on ensuring traceability and GMO-free integrity during handling and distribution of goods. Level III – Industrial Processing: Tailored for facilities involved in processing, manufacturing, or transforming raw agricultural products. Industries and Products Covered ProTerra Certification applies across a wide range of sectors such as agriculture, floriculture, horticulture, food processing, retail, and transport. Eligible products include but are not limited to: Soy, maize, rice, sugarcane, sunflower, rapeseed Fruits, vegetables, nuts, spices, and tea Bananas, coconut, palm oil, flowers, and plants Why Choose Shark Certification Pvt. Ltd.? Located in Indore, Shark Certification Pvt. Ltd. is your trusted partner for achieving ProTerra Certification. We combine industry expertise, global standards, and local knowledge to deliver reliable, timely, and cost-effective certification services. Our auditors are trained to work across multiple sustainability frameworks, allowing clients to bundle ProTerra Certification with complementary programs such as: Bonsucro ISCC Plus & ISCC EU RSPO Food Safety & Non-GMO Labeling Programs Key Benefits of ProTerra Certification Market Advantage: Meet rising global demand for sustainably sourced, GMO-free products. Brand Credibility: Enhance trust and reputation with independent third-party verification. Supply Chain Transparency: Ensure full traceability from farm to final product. Environmental Responsibility: Contribute to biodiversity conservation and climate action. Corporate Social Responsibility: Show commitment to fair labor practices and community welfare. Join the Global Movement for Sustainable Agriculture At Shark Certification Pvt. Ltd., we’re committed to helping producers, processors, and traders align with global best practices through ProTerra Certification. With rising awareness around the environmental and social impact of food systems, now is the time to showcase your dedication to a better future.

Ensure Transparency and Trust with Non-GMO Certification Offered by Shark Certification Pvt. Ltd., Indore As global consumers grow increasingly conscious about the origins of their food and feed, demonstrating that your products are free from genetically modified organisms (GMOs) has never been more important. At Shark Certification Pvt. Ltd., we help businesses build consumer confidence through Non-GMO Supply Chain Certification that verifies every step of production meets stringent non-GMO standards. What is Non-GMO Certification? Our Non-GMO Supply Chain Standard ensures that your product—whether it's a single ingredient or a fully processed food item—is traceable and compliant from seed to shelf. Certification is based on key EU regulations, including Directive 2001/18/EC, and Regulations 1829/2003 & 1830/2003, providing a robust foundation for global market access. This certification applies to: Seed Providers and Farmers Traders and Processors Storage and Transport Providers Sampling and Testing Laboratories We conduct independent audits of your quality management systems, focusing on GMO traceability, legal compliance, and proper labelling practices throughout the entire supply chain. Certified organizations are subject to annual surveillance audits to maintain ongoing compliance and market credibility. Key Areas Covered Under the Standard Seed selection and GMO-free verification Crop cultivation, harvest, and post-harvest handling Transportation and warehousing procedures Processing and packaging operations Sampling, testing, and analytical methods Final product labelling and legal compliance This certification is ideal for companies aiming to demonstrate full transparency, reduce risk, and meet consumer expectations in the non-GMO food and feed markets. Protect Ecosystems with Non-Biome Supply Chain Certification In response to increasing concern over deforestation and biodiversity loss—particularly in sensitive regions like the Brazilian Amazon Biome—Shark Certification Pvt. Ltd. also offers Non-Biome Supply Chain Certification for organizations sourcing soybeans from Brazil. Since 2006, a collective agreement has prevented the trade of soybeans grown in the Amazon Biome, helping curb illegal land conversion and environmental degradation. Our certification verifies that your soy products are sourced exclusively from areas outside the protected biome, in line with this long-standing agreement. Benefits of Non-Biome Certification Ensure soy sourcing aligns with global sustainability efforts Reduce environmental impact associated with deforestation Strengthen your brand’s environmental responsibility Maintain traceability and accountability in sourcing Meet buyer and stakeholder demands for eco-conscious sourcing Like our other services, this certification does not replace compliance with national or international regulations, but it does enhance your market reputation by demonstrating responsible sourcing practices. Why Choose Shark Certification Pvt. Ltd.? Located in the heart of Indore, Shark Certification Pvt. Ltd. is a trusted partner for businesses seeking credible, third-party verification in the areas of sustainable agriculture, food safety, and supply chain integrity. Our team of experienced auditors and compliance experts are here to guide you through every step of the Non-GMO or Non-Biome certification process, ensuring a smooth, efficient, and transparent experience. Certify Non-GMO Products with Confidence If you're ready to showcase your commitment to safe, traceable, and environmentally responsible products, Shark Certification Pvt. Ltd. is here to help. Whether you're a farmer, food processor, trader, or logistics provider—we provide end-to-end certification solutions tailored to your role in the supply chain. Contact us today to begin your certification journey and strengthen your position in the sustainable and non-GMO marketplace.

CE Marking Certification in Indore At Shark Certification Pvt. Ltd., we assist manufacturers, exporters, and importers in obtaining CE Marking, which is a critical requirement for products entering the European Economic Area (EEA). CE Marking signifies that a product complies with harmonized European standards and meets essential requirements related to health, safety, and environmental protection. What is CE Marking? CE stands for Conformité Européenne, meaning European Conformity. It is not a quality label, but a mandatory declaration of conformity indicating that a product adheres to applicable EU directives and regulations. By affixing the CE Mark, the manufacturer takes full responsibility for the product’s compliance with relevant EU legislation—allowing free movement and market access across all EU member states, including Iceland, Liechtenstein, and Norway. Why is CE Marking Important? ✔ Market Access to the EU – Acts as a trade passport for seamless entry into the European market ✔ Compliance with Unified Standards – Ensures that the product complies with standardized EU regulations instead of varying national rules ✔ Increased Buyer Confidence – Demonstrates product safety, regulatory compliance, and adherence to environmental standards ✔ Avoids Legal Barriers – Eliminates the need for re-certification across multiple EU countries ✔ Mandatory for Certain Products – Essential for machinery, electrical devices, toys, medical equipment, construction materials, and more Applicable EU Directives Include: Machinery Directive (2006/42/EC) – For safety in design and operation of machinery Low Voltage Directive (2014/35/EU) – Applies to electrical equipment operating between 50–1000V AC and 75–1500V DC EMC Directive (2014/30/EU) – Ensures electromagnetic compatibility of electrical and electronic devices Medical Device Directive, Toy Safety Directive, RoHS, and more – Based on product category Steps to Obtain CE Marking Identify Relevant Directives & Standards Determine which EU legislation applies to your product, including applicable harmonized standards. Product Evaluation Assess whether the product meets essential health, safety, and environmental protection requirements. Product Testing Conduct in-house or third-party testing based on specific directive requirements. Compile Technical Documentation Create a technical file including: Product specifications and risk assessment Test reports and certifications Declaration of conformity User manuals, safety data sheets, etc. Affix CE Marking Once conformity is ensured, apply the CE logo to your product and issue the formal EU Declaration of Conformity. Documents Required for CE Marking Product Specifications and Description Relevant Test Reports Risk Assessment Report Manufacturer’s Declaration Proof of Conformity with EU Regulations Technical Construction File Why Choose Shark Certification Pvt. Ltd. for CE Marking? At Shark Certification Pvt. Ltd., we bring deep regulatory expertise and a client-centric approach to guide you through the entire CE Marking process. Whether you're a domestic manufacturer or an international exporter, we support you in: ✅ Identifying applicable EU directives and standards ✅ Conducting gap analysis and risk assessments ✅ Coordinating required product testing ✅ Preparing all technical and regulatory documentation ✅ Liaising with notified bodies, where needed ✅ Achieving full CE compliance and affixing the CE logo Confidently Enter the EU Market with Shark Certification With a team of qualified experts and in-depth knowledge of EU compliance pathways, Shark Certification Pvt. Ltd. ensures that your product meets all legal obligations under CE Marking. Let us help you navigate regulatory complexity and unlock new global market opportunities. 📞 Contact us today for expert CE Certification support tailored to your industry and product type. Shark Certification Pvt. Ltd. provides reliable and expert CE Certification services in Indore, guiding businesses through the process of ensuring their products meet European Union standards. CE Certification is essential for verifying that products meet the safety, health, and environmental requirements set by the EU before being sold within its market. With years of experience in certification, Shark Certification Pvt. Ltd. offers professional advice and support, ensuring that your products comply with all necessary regulations. Their process is straightforward, covering everything from initial product assessment to testing and final certification, with customized solutions tailored to your specific needs. The company prioritizes efficiency, ensuring a swift certification process to help you bring your products to market quickly. Achieving CE Certification not only guarantees compliance but also enhances your product's global credibility. Shark Certification Pvt. Ltd. serves multiple industries such as electronics, machinery, medical devices, and toys, offering continuous assistance to ensure your products remain in compliance. For businesses in Indore looking for dependable CE Certification services, Shark Certification Pvt. Ltd. is the trusted partner to help you meet EU regulations and expand your market reach.

Strengthen Your Sustainability Profile with Ecovadis Certification By Shark Certification Pvt. Ltd., Indore In today’s global marketplace, sustainability isn’t just a buzzword—it’s a business imperative. At Shark Certification Pvt. Ltd., we help organizations across industries demonstrate their commitment to ethical, environmental, and socially responsible practices through Ecovadis Certification Assessment Support. What is Ecovadis Certification? Ecovadis is the world’s leading platform for evaluating and sharing sustainability performance in business-to-business supply chains. It provides a comprehensive assessment of a company’s environmental, social, and governance (ESG) performance through a cloud-based platform, enabling businesses to benchmark their practices and show measurable improvements. The Ecovadis evaluation focuses on four key pillars: Environment Labor & Human Rights Ethics Sustainable Procurement Each company is rated based on its policies, practices, and results, with scores reflecting compliance with major global sustainability frameworks like the UN Global Compact, ILO Conventions, and the Global Reporting Initiative (GRI). Why Ecovadis Certification Matters Ecovadis is increasingly becoming a standard requirement for doing business with global clients and supply chains that prioritize sustainability. It helps companies: Showcase their commitment to responsible business practices Build trust with stakeholders and customers Attract sustainability-conscious investors and partners Identify and close gaps in current ESG strategies Improve supply chain transparency and accountability With a scorecard system that ranges from 0 to 100, the assessment not only highlights performance but also points toward areas for improvement and long-term growth. Our Ecovadis Certification Support Services Shark Certification Pvt. Ltd. provides end-to-end consulting and support to help your business prepare for and succeed in the Ecovadis assessment. Our services include: Gap Analysis – Review of current systems and processes against Ecovadis requirements Documentation Guidance – Help in preparing or refining policies, procedures, and records Training & Awareness – Workshops for your internal teams on sustainability expectations Submission Support – Hands-on help with uploading data and responding to assessment questions Improvement Roadmap – Post-assessment strategy for scoring higher and driving progress Whether you're applying for the first time or working to improve your previous rating, we tailor our services to fit your business size, structure, and sector. Why Partner with Shark Certification Pvt. Ltd.? Based in Indore, we bring deep expertise in sustainability certifications and a client-focused approach to every engagement. Our team understands the nuances of global sustainability standards and how to align your business practices with Ecovadis’ expectations. With our support, you’ll be able to strengthen your ESG profile, build stakeholder trust, and stay competitive in a fast-evolving marketplace. Take the Next Step Toward Sustainable Business Success As global supply chains prioritize ethical sourcing and sustainability, Ecovadis Certification is more than just a rating—it’s your company’s credibility in action. Let Shark Certification Pvt. Ltd. guide you through the process with clarity and confidence. Get in touch today to learn how we can support your Ecovadis certification journey and help your business lead with responsibility and integrity.

Apply For USFDA Certification In Indore Looking for comprehensive certification solutions? Shark Certification offers a wide range of services, including FSSC, BRC, HALAL, KOSHER, NGMO, GMP, USFDA, and ORGANIC. Let us guide you through the process. About the U.S. FDA The U.S. Food and Drug Administration (FDA) is a key federal agency under the United States Department of Health and Human Services. As part of the federal executive structure, the FDA plays a vital role in safeguarding public health by regulating a wide range of products including pharmaceuticals, food items, cosmetics, and medical devices. The FDA is responsible for the approval and oversight of: New pharmaceutical products, including biologics Food and feed additives for humans and animals Color additives used in consumables and cosmetics Select categories of medical equipment and devices To ensure that products entering the U.S. market meet stringent quality and safety standards, the FDA also conducts inspections in manufacturing units located outside the U.S., including facilities in India that export drugs and food items to the American market. These inspections are based on Current Good Manufacturing Practices (CGMP) standards set by the agency. Compliance and FDA Inspections During inspections, FDA officials assess the level of compliance with CGMP guidelines. If any deviations or concerns are observed, they are documented in Form 483. This form outlines specific areas of non-compliance and is discussed directly with the management team of the manufacturing facility. Alongside the Form 483, the agency provides an Establishment Inspection Report (EIR), indicating whether any further action is necessary. Companies are expected to respond to the Form 483 within 15 working days. While the response is not legally required, submitting a detailed reply outlining corrective actions is highly recommended to avoid escalation. If the response is inadequate or if violations are severe, the FDA may issue a Warning Letter. In critical cases, enforcement actions such as import alerts, product approval delays, or even revocation of manufacturing licenses can follow. The FDA Approval Process For a drug or high-risk medical device to receive FDA approval, the manufacturer must demonstrate that it is both safe and effective for its intended use. While the FDA itself does not conduct testing, it rigorously reviews the data and clinical trial results submitted by manufacturers. Approval is granted only after a thorough review by a multidisciplinary team of FDA experts—including statisticians, biologists, chemists, and clinicians. Why FDA Compliance Matters for Indian Manufacturers The U.S. remains one of the largest and most lucrative markets for pharmaceutical products. Over the past few decades, Indian pharmaceutical firms have gained a significant presence in the U.S. generics space. To maintain and grow this market share, ongoing compliance with FDA regulations is crucial. Shark Certification Pvt. Ltd. – Your FDA Compliance Partner At Shark Certification Pvt. Ltd., we specialize in helping pharmaceutical and medical device companies navigate the complex regulatory landscape of the U.S. FDA. Our goal is to provide tailored, efficient, and value-driven solutions that reduce compliance risks and enhance operational excellence. Our team comprises seasoned professionals with deep experience in FDA regulations, global quality standards, and risk-based auditing approaches. We support clients from audit readiness to submission preparation—ensuring both compliance and business continuity. Our Core Services CGMP and Pre-Inspection Audits Pre-Approval Inspection (PAI) Preparation Quality Assurance and Control System Development 21 CFR Part 11 & GAMP 5 Compliance & Audit Support IT System Validation and Audit Services Quality Risk Management System Development Process Analytical Technology (PAT) & Quality by Design (QbD) Process Validation and Documentation USFDA Audit Readiness Training Regulatory Submission Support: 510(k), PMA, NDA, ANDA, IND, IDE, DMF, PAS Specialized Expertise Areas End-to-end Quality System Implementation & Gap Analysis Data Integrity & Compliance Audits Vendor and Third-Party Audits Good Clinical Practice (GCP) Audits Risk Assessments and Due Diligence Reviews FDA Form 483 and Warning Letter Responses GMP Compliance for Pharmaceuticals and Medical Devices Partner with Shark Certification Pvt. Ltd. With an unwavering focus on regulatory excellence and global health standards, Shark Certification Pvt. Ltd. is your trusted partner for U.S. FDA compliance. Whether you're preparing for your first inspection or responding to regulatory observations, we provide the guidance, expertise, and support needed to achieve and sustain compliance.