10 FDA consultants

Experience: Owner & Principal Consultant · PharmQ Strategy Lab, LLC

Owner & Principal Consultant at PharmQ Strategy Lab, LLC since 2026; the profile describes her as a former FDA inspectorate leader. At the FDA she was Branch Director, Pharmaceutical Quality Programs, OPQO, ORA (2020–2025), Staff Director, ORA Team Biologics (2010–2020) and Consumer Safety Officer, CDER Office of Compliance (2003–2010).

Experience: Senior Consultant · Biologics Consulting Group, Inc.

Senior Consultant at Biologics Consulting Group, Inc. since 2012, and former Senior Regulatory Scientist at the FDA (2001–2012). The profile says he works on IVD devices, advising clients on regulatory requirements for their IVD products and helping them develop IVD applications, including CMC, preclinical and clinical sections.

Experience: President · FDA 510k Consulting, LLC

President at FDA 510k Consulting, LLC since 2011. The profile describes him as an FDA regulatory consultant and co-founder of a regulatory consulting firm that helps medical device manufacturers, importers, repackagers and relabelers bring new products to the U.S. market, specializing in the 510(k) Premarket Notification pathway.

Experience: FDA Regulatory Consultant President · GUERRA CONSULTING GROUP, INC.

FDA Regulatory Consultant President at GUERRA CONSULTING GROUP, INC. since 1999, which the profile says provides FDA-related consulting, auditing, training and validation compliance services to pharmaceutical, API, biotechnology, medical device and cosmetic companies. Former Supervisory Chemist (1990–1999) and Computer Specialist (1986–1990) at the FDA.

Experience: Principal Consultant - Owner Operator · De Novo MedTech FDA Consulting

Principal Consultant - Owner Operator at De Novo MedTech FDA Consulting since 2020, providing regulatory affairs consulting, product development strategy and quality management system implementation for medical device companies, including design change management and related FDA reporting. Former Vice President of Regulatory Affairs and Quality Assurance at Heraeus Medical Components (2019–2020).

Experience: President Owner Regulatory Consultant · Ensor Pharma Biotech Consulting

President Owner Regulatory Consultant at Ensor Pharma Biotech Consulting since 2025 and Partner at ELIQUENT Life Sciences since 2026; the profile describes her as an ex-FDA senior leader. Former Senior Global Managing Director and Vice President, Pharma Biotech Consulting at NSF (2024–2025) and Senior Vice President, Head of Global Strategic Compliance Consulting at Parexel (2022–2024).

Experience: Principal · FDA Compliance Group LLC

Principal at FDA Compliance Group LLC since 2007, and former Consumer Safety Officer, Investigator at the Food & Drug Administration (1989–2003). The profile says she was an FDA investigator in the Seattle and Denver District Offices and an FDA Medical Device Specialist, and that her firm's specialties include FDA-483 responses, Warning Letter responses, 510k submissions and PMA submissions.

Experience: Regulatory Affairs Consultant, Medical Devices · Shackelford Consulting Services, LLC

Regulatory Affairs Consultant, Medical Devices at Shackelford Consulting Services, LLC since 2025. Former Principal Consultant, Regulatory Affairs (2023–2025) and Principal Consultant, Regulatory (2020–2022) at Avania. The profile says she specializes in preparing and submitting 510(k)s, PMAs, IDEs, Q-submissions and de novos, and that she has FDA experience as a lead reviewer in the Gastroenterology and Renal Devices Branch.

Experience: Principal Owner · Stonecroft Consulting, LLC

Principal Owner at Stonecroft Consulting, LLC since 2016; the profile says she provides regulatory consultation to pharmaceutical, medical device, food and dietary supplement companies. At the FDA she was Senior Case Review Expert (2008–2015), Compliance Officer (2001–2008 and 1992–1999) and Supervisory Consumer Safety Officer (2000–2001).

Experience: FDA Regulatory Consultant · FDA Regulatory Consultants, LLC

FDA Regulatory Consultant at FDA Regulatory Consultants, LLC since 2019, and former FDA Consultant at Aegis Regulatory, Inc (2009–2019). The profile says she specializes in medical devices, cosmetics and radiation-emitting products, listing work on 21 CFR 820 quality systems, ISO 13485 and ISO 9001, compliance procedures and SOPs, labeling under 21 CFR 801 and annual reports for electronic products.