Assisting capital-allocators minimize the risk associated with your investment decisions. Respected and recognized former FDA investigators identify regulatory gaps that can fly under the radar, jeopardizing your investments. Make a safer decision and obtain bargaining power by enabling exFDA consultants to demonstrate how the FDA’s regulations will impact your investment.

Now available for Switzerland and EU. Ex FDA Consultants Authorized Representative serves as your liaison for products entering the Swiss and European markets. We fulfil these requirements as laws prescribe them. Read more to know how we can support your product’s marketing, sale, and compliance within Switzerland, Europe, and the United States.

FDA inspectors and submission reviewers offer world-class and globally recognized leadership for your manufacturing, design controls, and clinical trial needs. Whether it be US FDA, EU CE, MDSAP and others, we will develop, support, and stress-test your operation.

We anticipate the trend, offering leading Cyber Security services for Medical Devices. Following the 2022 FDA System Considerations and Content of Premarket Submissions, we offer our clients insight and guidance on developing their systems securely and advancing their Cyber Security posture by developing future-proof systems.

We offer a comprehensive ISO 27001 Audit Preparation service. We can guide you through the ISO 27001 implementation journey, helping to embed privacy and data protection into your organization's culture and operations. Whether you need to review your policies or implement new technologies, we can design a smoother path towards compliance.

We specialize in supporting regulatory compliance for foreign and domestic infant formula manufacturers. We can assess your adherence to current Good Manufacturing Practices (cGMPs), infant formula regulations (21 CFR Parts 106, 107, and 117), and other FDA guidelines specific to infant formula processing. With out in-depth knowledge of the agency's inspection techniques, compliance expectations, and decision-making processes, exFDA Consultants can help you navigate the complex regulatory landscape, develop corrective action plans, and execute successfully.

The Foreign Supplier Verification Programs (FSVP) is a critical regulation under the FDA Food Safety Modernization Act (FSMA). It places the responsibility on importers to ensure the safety of imported food for humans and animals by verifying that their foreign suppliers adhere to U.S. safety standards. This involves conducting hazard analyses, evaluating supplier risks, and implementing appropriate verification activities like audits, testing, or reviewing records. The FSVP aims to protect public health by preventing adulterated or misbranded food from entering the U.S. market. Importers must understand and comply with FSVP requirements to ensure the safety and quality of their imported products.