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Social Accountability & Sustanibility

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.

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Medical / Pharma Standards

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.

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Promoting organic production standards to meet consumer demand BUSINESS CHALLENGE Increased cases of unsafe food due to over use of chemical fertilizers and chemicals in food production system, has created an increasing worldwide demand for organic food. The challenge facing the organic agriculture industry is to produce foodstuffs and agricultural products using methods, which respect the environment and animal welfare. Globally, these demands are defined by regulations, particularly in those countries, which consume organic products. The principal standards are NPOP standard (India Organic- APEDA), EU Regulation 834/2007 and the US National Organic Program (NOP). To take into account the regulations in place, the certification scheme depends both on the country of production and the country of destination. This certification is aimed at producer organizations or members of food industries who want to commercialize organic products for a particular market. The organic certification considered as a guarantee of quality and safety by the consumers. What is Organic Certification? Organic certification is a nationally and internationally recognized set of standards aimed at proving that agricultural and food products have been produced without the use of synthetic chemical products, while using methods, which respect the environment and animal welfare. Organic requirements involve a set of production specifications for growing, storage, processing, packaging and shipping. All organic assessment and qualification references require control and certification by an accredited independent body. Organic Certification Requirements vary from country to country and generally involve a set of production standards for growing, storage, processing, packaging and shipping that include: avoidance of synthetic chemical inputs (e.g. fertilizer, pesticides, antibiotics, food additives), irradiation, and the use of sewage sludge; avoidance of genetically modified seed; use of farmland that has been free from prohibited chemical inputs for a number of years (often, three or more); for livestock, adhering to specific requirements for feed, housing, and breeding; keeping detailed written production and sales records (audit trail); maintaining strict physical separation of organic products from non-certified products; Undergoing periodic on-site inspections. Certified organic foods are not necessarily pesticide-free, certain pesticides are allowed. What are the key benefits? Demonstrate Organic Standards compliance of products to clients (retailers, traders, importers) Inspire consumer confidence Ensure greater access to existing and target markets Help protect the environment from harmful products and processes Preserve animal welfare WHY CHOOSE SCPL We are working with USOCA that is accredited for certification according to the NPOP, Swiss, European and NOP (USDA) organic production standard. With the NPOP, the client will also get certificate for Swiss and European Organic certification (EU Regulation No. 834/2007), which will make it recognized by all European Union member countries. In order to access the US market, you have to certify your products to the National Organic Program (NOP).

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