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.

We are former colleagues and friends who have combined our networks to provide direct critical services.

We consist mostly of former FDA investigators, expert witnesses, and submission reviewers. Our experience in the field as officials can be your asset. Work with us, and you learn how FDA officials think and operate.

We offer an open-door policy for those who wish to contact us to explore ways to collaborate on projects.

We offer support for large and small projects from development to post-market surveillance. Whether you are starting out at the prototyping stage or initiating CAPAs for quality control and market surveillance, our team can assist you at all stages to give you confidence in your finished products.

We specialize in development, multi-site clinical trial support, diligence for manufacturing/contract manufacturing, and design transfer activities.

(including Drugs and Biologics)

Do you need assistance with design and development, design transfer, risk management, or validation? Perhaps, all of the above? Our team specializes in software, computer system validation, and defining requirements, protocols, and reports, for demonstrating adequate testing of design or manufacturing. Whether you may need support with design controls or an understanding of how to implement biocompatibility, sterility, or other types of complex specifications, we are here to help!

Who better than a former FDA Investigator or submissions reviewer to review your manufacturing processes, technical files, and overall compliance program? Our team of exFDA Investigators supports internal audits, market approval submissions, and support onsite inspections with regulatory authorities using the highest globally harmonized standards.

Our auditing service will stress test your operation so we can work with you to close gaps and prepare your team for a successful audit.

We offer support with market application submissions in the areas of MDR, IVDR, MDSAP, US FDA (510k, PMA, NDA, BLA), and Clinical Studies.

Even if you are in the early stages of development, we can guide you in communications with a regulatory body to get a direct assessment from your regulatory authority. An example of this would be the Q-Submission to the US FDA. The Q-Submission is a no charge no obligation assessment by the FDA to assist you in the development of your product or service.

Becoming compliant with regulations does not mean you will stay in compliance.

If you are concerned a part of your system is no longer compliant, we recommend an internal audit.

Ensure you stay compliant with industry-standard practices closest to a regulatory authority’s mindset. We assist with post-market surveillance, corrective and preventive actions, 483 and warning letter responses, internal audits, mock inspections, compliance gap assessments, risk management, and change management. We will train your team to conduct FDA-style internal audits to ensure you stay compliant independently.

Selecting clinical trial management software is not even the beginning. We have seen firsthand how the misuse of CTMSs has resulted in million-dollar blunders. In addition to training and assigning staff, it is fundamental and critical that every process of your system is validated.

Once validated, the system needs to be regularly tested and monitored. We have experience with these systems to help you properly implement and maintain compliance. Prevent costly mistakes and time with the right foundation.

As close as it gets. Hire Direct.