ECO VADIS Certification

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

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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Social Accountability & Sustanibility

SA 8000 Certification

The SA 8000 certification is the Social Accountability System standard. It is applicable to companies of any size that wish to address the social and ethical aspects of their business. A Social Accountability System proves to customers that the company holds adequate provisions for the protection of workers’ rights. Further, it ensures ethical production of all goods manufactured by the company. SA 8000 certification enables organization’s to demonstrate your commitment to social accountability standards as well as employee and customer satisfaction. SA 8000 is an international certification standard that encourages organization to develop, maintain and apply socially acceptable practices in the workplace. It was created in 1989 by Social Accountability International (SAI), an affiliate of the Council on Economic Priorities, and is viewed as the most globally accepted independent workplace standard. It can be applied to any company, of any size, anywhere in the world. The areas it addresses include forced and child labor, health and safety, freedom of association and collective bargaining, discrimination, disciplinary practices, working hours, compensation and management systems. Along with setting standards for employees worldwide, SA 8000 also embraces existing international agreements, including conventions from the International Labor Organization, the Universal Declaration on Human Rights, and the United Nations Convention on the Rights of the Child. SA 8000 Key Requirements Be senior management led Be focused on continuous improvement Be focused on prevention rather than reaction Be supportive of workers rights and workers participation Be compliant with local laws/codes Be compliant with local laws/codes Be systematic in addressing problems-Car’s Process Benefits of SA 8000 Certification Marketing advantage -more demand and value for goods from socially Responsible manufacturers and suppliers Enhancement of company’s productivity. Compliance to the laws of the land Improvement of relationship with the Govt., NGOs, trade unions Better image and position in labor markets Cost reduction in monitoring Better corporate image Increased value for the products Trust building with the analysts and investors when evaluated against social performance

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QMS & EHS Standards

ISO 50001 Certification

With the rising need to save energy, most companies today are putting their maximum efforts to promote better energy consumption. Having the best energy efficiency credentials are a must for your business and also for the promotion of your business too. Having an ISO 50001 certification would mean better savings and also better commitment towards the environment. Because you would be using an energy management system with a quality standard you would be able to reduce wastage within your organization. When you look at this event on a long term basis, you would be saving a lot of money and thus protecting the environment too. We at SHARK make sure that the entire certification process is simple and easy. We understand your existing set up first and figure out the drawbacks when compared to ISO 50001 requirements. This will help your organization understand business areas where you need to focus on more to receive your certification. These changes could be processes and procedures that need to be added to your existing setup for better productivity. This would help you understand the areas to be worked upon before a formal assessment, thus saving you valuable time and money. Once the conduct the formal assessment for ISO 50001 certification, we will share details of our study that will show the areas to develop. If all the requirements are in place, we will assess the different implementations and proceed with the energy management system quality certification. Having such a quality standard for your EMS would mean that your business is managing energy efficiently. It would mean that your greenhouse gas emissions are within the permissible limits and that EMS is working towards meeting environmental targets. Such a certification would prove that your business is a responsible one and keeps energy management as its most important target. With the rising need to save energy, most companies today are putting their maximum efforts to promote better energy consumption. Having the best energy efficiency credentials are a must for your business and also for the promotion of your business too. What is ISO 50001 Certification? It is a quality system model that aims at continuous improvement that is focused towards the energy management of a company. With standards like this, you can be assured to integrate energy management as the top priorities of the company. Once the conduct the formal assessment for ISO 50001 certification, we will share details of our study that will show the areas to develop. If all the requirements are in place, we will assess the different implementations and proceed with the energy management system quality certification. Benefits of ISO 50001 Certification Having such a quality standard for your EMS would mean that your business is managing energy efficiently. It would mean that your greenhouse gas emissions are within the permissible limits and that EMS is working towards meeting environmental standards. Such a certification would prove that your business is a responsible one and keeps energy management as its most important target.

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QMS & EHS Standards

ISO 29990:2010

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

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QMS & EHS Standards

ISO 9001, ISO 14001, or ISO 45001 certification

Get ISO Certified with Shark Certification Pvt. Ltd. – Indore’s Trusted ISO Consultants Shark Certification Pvt. Ltd. is a leading ISO consultancy firm based in Indore, offering end-to-end support to organizations looking to implement internationally recognized management systems and obtain ISO certifications. With an expert team and a client-focused approach, we simplify the certification journey for businesses of all sizes. We specialize in providing consultancy services for the following key ISO standards: ✅ ISO 9001:2015 – Quality Management System (QMS) ISO 9001 is the world’s most recognized quality management system standard. It provides a framework for businesses to ensure consistent product and service quality, enhance customer satisfaction, and continuously improve operations. Benefits of ISO 9001 Certification: Improved customer satisfaction and loyalty Streamlined operations and enhanced internal processes Increased marketability and credibility Better decision-making based on data and performance insights Stronger focus on risk management and continual improvement Our Services Include: Gap analysis and QMS implementation support Internal audits and training Preparation for third-party audits Complete documentation and process alignment Assistance in maintaining and renewing certification ✅ ISO 14001:2015 – Environmental Management System (EMS) ISO 14001 helps organizations manage their environmental responsibilities efficiently. It enables companies to reduce environmental impact, comply with regulations, and demonstrate a commitment to sustainability. Benefits of ISO 14001 Certification: Reduction in waste and resource consumption Compliance with environmental laws and regulations Enhanced environmental performance and reputation Improved stakeholder and public trust Identification of environmental risks and opportunities Our Services Include: Environmental impact assessment and EMS setup Compliance analysis and legal requirement mapping Documentation and procedural implementation Internal audits and corrective action guidance Audit preparation and certification support ✅ ISO 45001:2018 – Occupational Health & Safety Management System (OHSMS) ISO 45001 is an international standard that focuses on reducing occupational injuries and diseases. It helps businesses create a safe and healthy workplace for employees, contractors, and visitors. Benefits of ISO 45001 Certification: Enhanced employee safety and workplace morale Reduction in accidents, incidents, and legal liabilities Compliance with national and international safety regulations Cost savings through fewer disruptions and improved productivity A proactive approach to risk prevention and hazard control Our Services Include: Health & Safety risk assessments OHSMS framework development and policy creation Staff training and safety awareness programs Internal safety audits and compliance reviews Support through the certification and surveillance process Why Choose Shark Certification Pvt. Ltd. in Indore? Expert ISO Consultants with industry-specific knowledge Tailored solutions based on your organization’s size and operations Transparent process with end-to-end documentation support Affordable pricing and fast-track certification Ongoing support for audit preparation, renewals, and training Trusted by 1000+ organizations across sectors Let’s Get Started! If you're ready to elevate your business through ISO 9001, ISO 14001, or ISO 45001 certification, partner with Shark Certification Pvt. Ltd. – Indore’s trusted name in ISO consultancy.