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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.

‘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

Learning services for non-formal education and training – Basic requirements for service providers The objective of this International Standard is to provide a generic model for quality professional practice and performance, and a common reference for learning service providers (LSPs) and their clients in the design, development and delivery of non-formal education, training and development. This International Standard uses the term “learning services” rather than “training” in order to encourage a focus on the learner and the results of the process, and to emphasize the full range of options available for delivering learning services. This International Standard focuses on the competency of LSPs. It is intended to assist organizations and individuals to select an LSP who will meet the organization’s needs and expectations for competency and capability development and can be used to certify LSPs. ISO 29990:2010 is an International Standard for providers of training and further training. It offers a certifiable and state of the art Standard according to ISO requirements for Management Systems. The Standard addresses – for the first time with international validity – all types of educational institutions. This includes single trainers, private seminar providers, organizations providing further training with courses, curricula and internal training as well as further training up to higher educational institutions and universities. The Standard has some congruent features with other management systems, above all with ISO 9001 .ISO 29990 is basically subdivided into two areas: learning services (for example, these services include designing, providing and monitoring of learning services) and management at the learning service provider for example business planning, financial management, risk management as well as human resources management. This Standard is the first Standard for learning providers that is valid and applied on an international scale. The advantages for learning providers are transparency of their own services, international comparability and defined processes for quality assurance. BENEFITS of ISO 29990:2010 Advantages for Learning Service Providers:- Outstanding performance during tendering work from official bodies. Globally marketability. Enhancement in internal quality potential. Transparently defined & documented processes. Enthusiastic and active trained experts participation in the development. Work on (PDCA) Cycle. Advantages for Learner:- Adequate resources, including trainers with suitable competence, infrastructure and learning environment. Evaluating criteria for Education. Advanced & Authentic processes. Transparency/comparability of services. Assuring quality, transparency and comparability in educational institutions. Benefits for Global Cooperation Base of development for international cooperation in the area of education and training Globally comparable benchmarks for existence of quality. No deformation of the globally competitive market. Common unified standards/common understanding of quality

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