EUDR Certification

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.

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Medical / Pharma Standards

USFDA Certification

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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Food Safety Standards

Fssai Compliances

FSSAI Compliance Services in Indore By Shark Certification Pvt. Ltd. – Your Trusted Food Safety Partner Under Section 31(1) & 31(2) of the Food Safety and Standards Act, 2006, every Food Business Operator (FBO) in India is legally required to obtain FSSAI Registration or License—whether you're a street vendor or a multi-national food brand. At Shark Certification Pvt. Ltd., we offer complete FSSAI compliance services to help food businesses across Indore and India meet mandatory regulatory requirements with ease and confidence. Who Needs FSSAI Registration or License? The FSSAI License/Registration is mandatory for businesses including (but not limited to): Small vendors, hawkers, and temporary or permanent food stalls Dairy businesses and milk chilling units Edible oil and vegetable oil processing units Slaughterhouses and meat processing facilities Food manufacturers, processors, and packaging units Proprietary and novel food producers (with FSSAI product approval/NOC) Cold storage, warehouse operators, and transporters (including refrigerated vans, milk tankers) Wholesalers, distributors, marketers, and retailers Hotels (star/non-star), restaurants, bars, and food chains Canteens, caterers, messes, clubs, and food vending agencies Home kitchens, dabbawalas, banquet halls, and religious food arrangements Importers, exporters, and e-commerce food businesses Government departments, corporate food outlets, airports, seaports, railways, and bus depots Mid-day meal kitchens and public food distribution centers Our FSSAI Compliance Services Include: At Shark Certification, we offer end-to-end FSSAI compliance support for businesses of all sizes and industries: New FSSAI Registration / State License / Central License Renewal of existing Registration or License Modification of license details including product category, address, or business structure Annual Return Filing (Form D1 / D2) and related declarations Assistance in Revocation of Suspended Licenses FSSAI Certified Training for FBOs and staff by qualified food safety trainers Facility Hygiene Audits by certified auditors Pre-inspection Surveys to prepare for official FSSAI audits and fix gaps before inspection Consultation on Labeling, Packaging, and Legal Metrology Norms Timely Alerts and Reminders for license renewal and return filing Why Choose Shark Certification Pvt. Ltd.? Certified Experts with deep industry and regulatory experience Accurate and Error-Free Filing with proper due diligence Confidentiality and Data Security assured Local Presence in Indore for better accessibility and faster service Free Initial Consultation to assess your FSSAI readiness Customized Compliance Plans for startups, SMEs, and large enterprises Training and Support throughout the certification journey Renewal and Filing Alerts via WhatsApp, Email, and SMS Updated Insights and Newsletters for food businesses Contact Us Today Ready to get your FSSAI Registration or License in Indore or any part of India? Let the experts at Shark Certification Pvt. Ltd. guide you through every step—from documentation to audit support.

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Product Certification

AGMARK & BIS Certification

‘Agmark’ is a Quality Certification Mark of the Government of India given to products confirming to scientifically laid down quality standards. Products commonly certified under AGMARK Honey Ghee, Butter Chillies, Turmeric, Curry powder, Garam Masalas, Cardamom, Cumin, Coriander and other curry powders. Vegetable Oils Spices Wheat, Atta, Maida, Suji, Besan, Pulses and many more items required by customers. Certificate of Authorization It is given to the packers authorizing them to grade their Commodity under AGMARK. Period of Validity will be 5 years. For granting new certificate of authorization separate application for each commodity should be produced. Documents to be given along with application Sketch of the premises:- Declaration regarding Proprietorship/Partnership etc Ownership of the premises Ownership of trade brand label Use of good grade quality containers for packing commodities. All declarations has to given in five rupees stamp label attested by notary public. A copy of licence from Panchayat/Municipality. Bank reference:- Letter from the bank regarding the transaction to the packer with the bank List of machineries. Specimen signature of authorised persons attested by the proprietor / managing partner. Medical fitness certificate of employee. Specimen copy and sketch of trade brand label

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NABL Certification

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.

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Food Safety Standards

Ayush Certification

VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS Introduction The Ayush products are regulated under the Drugs and Cosmetics Act, 1940 by the Drugs Controller General of India through the State Governments. The Department of AYUSH has been exploring the possibility of introducing a voluntary product certification scheme for selected AYUSH products to enhance consumer confidence. The matter was discussed in a series of meetings taken by the Secretary (AYUSH) beginning 24 Dec 2008 and the Quality Council of India (QCI) offered to develop a concept paper on the subject. On approval of the concept, the Department of AYUSH signed an agreement with the QCI on 27 July 2009 to design the Scheme with Department of AYUSH being the Scheme owner and QCI being responsible for managing the Scheme. The draft Scheme was given to the Department of AYUSH on 3 Aug 2009 and Simultaneously placed on the websites of Department of AYUSH and QCI for public consultation. The Scheme will be overseen by a Multi stakeholder Steering Committee (MSC) chaired by the Secretary (AYUSH) with secretariat in QCI. The MSC will be supported by a Technical Committee and a Certification Committee constituted by QCI. The Scheme is based on a criteria for certification. It has two levels: Ayush Standard Mark which is based on compliance to the domestic regulatory requirements Ayush Premium Mark which is based on GMP requirements based on WHO Guidelines and product requirements with flexibility to certify against any overseas regulation provided these are stricter than the former criteria. Under this scheme, each manufacturing unit would obtain a certification from a approved certification body (CB) which is accredited to appropriate international standards by the National Accreditation Board For Certification Bodies (NABCB) and will be under regular surveillance of the certification body.

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QMS & EHS Standards

ISO 9001:2015 QMS Certification

The International Standards specify requirements for quality management systems where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements and aim to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. The ISO 9001 certification defines good management practices and aims at providing a global standard that spells out quality and trust. A Quality management system can be used by an company in any industry. Since the standard is neither industry- nor product-specific, it may be used by any organization that provides a product or service. The ISO 9001 standard enable company to develop a Quality Management System (QMS) to meet customer quality requirements while progressively improving operational processes. It provides company with a set of principles that ensure a common sense approach to the management of your business activities to consistently achieve customer satisfaction. What is quality management system? It is the much desired framework that is needed to monitor and improve performance in any specialized area of your business. It could improve the way your business operates or it could help you bring down your operating costs. Benefits of quality management system Higher levels of efficiency: With the ISO 9001 Certification, you can be assured of better performances within the company. Your employees would be working towards a common goal and this would increase the performance of each department. Better belief in the company: Employees always want to work with the best quality standards in place. Better brand image: having the right brand image is an important part of every business. Having a QMS implemented would lead to a good brand image within the industry, clientele and your competitors. Why ISO 9001:2015 certification? ISO 9001:2015 is a standard that sets out the requirements for a quality management system. It helps businesses and organizations to be more efficient and improve customer satisfaction. This is generic standard can be deployed across all industries. ISO 9001:2015 now follows the same overall structure as other ISO management system standards (known as the High-Level Structure), making it easier integrate multiple management systems. Another major difference is the focus on risk-based thinking; the new version gives it increased prominence. ISO 9001:2015 brings a number of benefits ISO 9001:2015 puts greater emphasis on leadership engagement Helps address organizational risks and opportunities in a structured manner Uses simplified language and a common structure and terms, which are particularly helpful to organizations using multiple management systems, such as those for the environment, health & safety, or business continuity Addresses supply chain management more effectively Is more user-friendly for service and knowledge-based organizations Advantages: Greater Assurance of meeting objectives as risk based thinking applied all across in the organization. Integration of QMS into business processes, as accountability of QMS lies with top management. Clear strategic direction of an organization as context of the organization is part of QMS. Promotion of leadership across organization. More reliable Product/Services as risk based approach is used for more effective and efficient service/product provision processes Customer satisfaction – through delivery of products that consistently meet customer requirements More Specific Benefits Reduces cost Improves product reliability Better process control and flow Better documentation of the processes Greater employee quality awareness Increased Productivity Certification Procedure The Certification Procedure is a multiple-step process. The certification cycle is described briefly: Applying for Certification (Turnkey Project) Consultancy/ Documentation & System Development as per Standard Pre audit (optional) Certification audit – (Stage 1 + Stage 2) Issue of certificate on successful completion of certification audit Surveillance audits at defined period Recertification audit after 3 years