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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.

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.

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.

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.

Europe is a competitive but prize market, easier to access than ever before. Too many Indian exporters, especially small and medium sized enterprises, avoid it because the technical requirements for entry seem too complicated, too difficult, or too expensive. Indian manufacturers who have successfully accessed the European market know that the time to understand the European system is well worth the effort. The European Union alone is filled with affluent consumers, approximately 450 million of them. The European market is a large area that comprises more than 25 countries. For the exporter, therefore, Europe as a whole has become a market whose technical requirements have been greatly simplified. Before the creation of the European Union, each country imposed its own technical requirements. Different standards and conformity assessment procedures forced exporters to target one or two countries only, or to forego exporting to Europe altogether. The unification of these European countries into a European Union, and the consequent harmonization of laws, standards, and conformity assessment procedures, changed all that. Perhaps more importantly, ISO 9001 Certification is used extensively in Europe as a condition of acceptance of a manufacturer’s product or as a means of recognition of the manufacturer’s credibility. It is important to note that a manufacturer with a quality system in place (such as ISO 9001 QMS) should not automatically assume that his or her products are CE compliant because of the quality system alone. The appropriate New Approach Directive(s) will prescribe the correct and full route to conformity assessment. The CE Mark, which is affixed to a product or its packaging, is considered a proof that the product has met the requirements of the harmonized European standard, or directives; refers to Communauté European. Translated from the French, this literally means European Community. The European Commission, which administers the program, describes the CE Mark as a passport for goods to be sold freely within the internal European market. It is required by law if the product falls under one of the New Approach Directives. It is not a quality mark, nor is it a mark for consumers. Intended for Member State authorities, it is the visible sign to those authorities that your product is in compliance with the New Approach Directives. All manufacturers are required to affix the CE mark to products that are governed by New Approach Directives. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product. The first step to compliance is determining which directives apply to the product. A product may be regulated by more than one directive. The CE mark does not disclose which directive(s) or standards apply to the product, nor will it indicate the method of conformity assessment used to bring the product into compliance. This information is provided by other accompanying documents, such as the Declaration of Conformity. The Manufacturer or the Authorized Representative affixes the CE marking to the product. It is not affixed by a Notified Body.

‘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

“License to operate in the International Feeds Sector.” FEED SAFETY CHALLENGE Feed Safety and Quality are key issues for all companies handling feedstuffs and can have serious consequences when control is lost. A systematic approach is imperative for reducing risk and improving quality. Companies seeking to internationalize their business in Europe must be certified to a standard recognized by the GMP+ International (former PDV) organization. The GMP+ certification is also recognized by other feed certification schemes. Knowledge of GMP+ is spreading and the certificate is requested at a continuously greater extent throughout the world. The GMP+ regulations are in a process of continuous development and improvement and changes are relevant to all organizations in the international supply chain. WHAT ARE GMP+ STANDARDS BASED ON? The GMP+ standards have been developed to harmonize requirements for feed in order to ensure quality and safety throughout the entire feed chain. It is based on widely recognized principles of quality assurance, Hazard Analysis Critical Control Point (HACCP). Choosing which standard (B1, B2, etc.) and certification scope (production of feed materials, trade, etc.) depends on the organization’s role in the feed chain. GMP+ B1 is mandatory for the production of compound feed, but can also be used for the production of feed materials and transport. B2 can be used for the production of feed materials and feed additives, while B3 is intended for trade and transshipment. Each of these standards is intended for different means of feed transport (e.g. B4.1 is intended for truck transport). All steps in the supply chain are thus covered by the given requirements. Advantages of GMP+ certification Companies benefit from GMP+ certification, because it: is focused on quality management (ISO 9001) and risk management (HACCP); provides access to supporting information and services, such as risk assessments, fact sheets, storing and sharing your monitoring data, newsletters, Early Warning messages etc); Offers new sales opportunities and to a great degree, ensures the retention of current customers; Guarantees the continuity of business operations, because the corporate structure is set up more efficiently and the costs and financial risks are limited; Helps improve the company image and the reliability; Makes your company part of a globally operating feed safety system (the GMP+ certificate is accepted internationally by about 12000 companies in 66 countries); Is accepted by other (inter)national schemes; Can easily be combined with multiple certifications (feed safety and sustainability); Contributes to uniformity in the feed chain.

We provide consultancy service for GMP WHO certification to our clients. GMP (Good Manufacturing Practices) is a standard defined by WHO (World Health Organization). GMP WHO certification ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. W.H.O. defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization”. GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures taken; full traceability of a product through batch processing records and distribution records; and systems for recall and investigation of complaints. The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. There are many ways this is controlled – controlling the quality of the facility and its systems, controlling the quality of the starting materials, controlling the quality of production at all stages, controlling the quality of the testing of the product, controlling the identity of materials by adequate labeling and segregation, controlling the quality of materials and product by adequate storage, etc. All of these controls must follow prescribed, formal, approved procedures, written as protocols, SOPs, or Master Formulae, describing all the tasks carried out in an entire manufacturing and control process. GMP covers all aspects of the manufacturing process including : Defined manufacturing process Validated critical manufacturing steps Suitable premises, storage, transport, qualified and trained production and quality control personnel Adequate laboratory facilities Approved written procedures and instructions Records to show all steps of defined procedures have been taken Full traceability of a product through batch records and distribution records Systems for recall and investigation of complaints

FSC Certification in Indore Your Trusted Partner – Shark Certification Pvt. Ltd., Indore With increasing global demand for environmentally responsible products, FSC® (Forest Stewardship Council®) Certification has become a critical requirement for businesses engaged in the wood, paper, packaging, printing, and furniture industries. At Shark Certification Pvt. Ltd., we provide expert consulting and end-to-end support for obtaining FSC and PEFC certifications across India. What is FSC Certification? FSC Certification ensures that products sourced from forests—such as timber, paper, and packaging—are obtained responsibly and sustainably, with due consideration for the environment, communities, and economies. Businesses certified under FSC are allowed to use FSC labels, providing assurance to consumers and buyers that their products meet global sustainability standards. Why is FSC Certification Important in India? India’s growing export markets, especially in packaging, furniture, handicrafts, pulp & paper, and print, increasingly demand FSC-certified products. Global buyers now require FSC-labeled goods like corrugated boxes, paper bags, hang tags, and other wood-based materials. While large Indian companies have paved the way, now SMEs are also realizing the value of FSC certification to expand their global reach and credibility. Types of FSC Certificates The type of FSC certification you need depends on your role in the supply chain: FSC Forest Management (FM) – For forest owners and managers to demonstrate responsible forestry practices FSC Chain of Custody (CoC) – For manufacturers, traders, and processors ensuring traceability from forest to final product FSC Controlled Wood – For companies that mix FSC and non-certified wood, verifying the non-certified portion meets FSC’s risk mitigation requirements FSC Labels You Can Use Once certified, your business may use one of the following FSC labels based on sourcing and production: FSC 100% – Made entirely from FSC-certified forests FSC Mix / FSC Mix % / FSC Credit – Blend of FSC-certified and controlled sources FSC Recycled – Made from reclaimed materials Challenges in the Indian Market – and How We Help Despite the rising demand, several challenges remain in the Indian ecosystem: Limited FSC Certified Forests: Most FSC-certified timber is imported due to low domestic coverage under Forest Management certification Few FSC Certified Traders: While manufacturers and mills may be certified, FSC-certified traders and distributors are still scarce Gaps in Awareness: Many SMEs are unaware of the process, cost, or benefits of certification Shark Certification Pvt. Ltd. bridges this gap by providing: Complete certification roadmaps and training Help with locating FSC-certified suppliers and materials Pre-audit assessments and documentation support Ongoing consultation to maintain compliance and renewals FAQs: Your FSC Questions Answered Do I need FSC certification if my supplier is certified? ✅ Yes. If you wish to sell your products as FSC-certified, your company must also be certified—even if you use FSC-certified raw materials. How do I get FSC certified? ✅ The process begins with identifying the applicable FSC certificate type. Then, an accredited FSC Certification Body conducts an audit of your operations. On successful completion, you’re issued an FSC certificate and added to the global FSC database. How much does it cost? ✅ Cost depends on company size, scope, and audit complexity. We offer transparent pricing and affordable options tailored for MSMEs and larger organizations alike. Why Choose Shark Certification Pvt. Ltd.? ✅ Located in Indore, serving pan-India clients ✅ Expertise in FSC, PEFC, and other sustainability certifications ✅ Fast, efficient turnaround with practical guidance ✅ Support in finding FSC-certified materials and vendors ✅ Personalized, end-to-end support—from readiness to certification and beyond Get FSC Certified with Confidence If you’re looking to unlock export potential, win global clients, or contribute to sustainable practices, FSC certification is the way forward. Let Shark Certification Pvt. Ltd. guide you with clarity, speed, and reliability.