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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.

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.