Reginald D. Neal

Reginald D. Neal

Senior Consultant

Reginald joined Biologics Consulting in 2006. Prior to that time, he served as a Senior Reviewer and Lead CGMP inspector in the Division of Manufacturing and Product Quality (DMPQ), Office of Compliance and Biologics Quality (OCBQ) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), since 1999. Reginald has 27 years of experience working for the U.S. federal government, including the Department of Health and Human Services/U.S. Food and Drug Administration, Department of Agriculture, Department of the Navy, Department of Commerce and Department of Interior/U.S. Fish and Wildlife Service.

Reginald began his FDA career in 1988 with the Office of Regulatory Affairs as a Consumer Safety Officer (CSO) where he conducted a wide range of inspectional and investigational assignments to include bioresearch monitoring audits, drug inspections, Good Laboratory Practice (GLP) inspections/audits, biologics inspections, and medical device manufacturing inspections. In 1995, Reginald joined CBER, OCBQ, Division of Inspections and Surveillance (DIS) as Bioresearch Monitoring Reviewer. As a Senior Reviewer and Lead CGMP inspector in CBER/OCBQ/DMPQ, Reginald gained extensive experience in evaluating pharmaceutical product facility design, assessment of validation approaches, and evaluation/development of regulatory strategy through representing CBER at numerous Type C meetings (i.e., facility, validation, and regulatory strategy related) with industry. Reginald has provided extensive advice to industry on regulatory strategy and best practices to meet FDA licensing requirements.

During his four-year tenure in DIS (1995 – 1999) and six-year tenure in DMPQ (1999 – 2006), Reginald gained experience with products that span the entire portfolio of CBER regulated products including viral and bacterial vaccines, recombinant therapeutic products, blood fractionation products and in vitro diagnostic test kits. His inspection experience includes leading inspections of drug substance and drug product manufacturers, aseptic filling and finishing facilities, lyophilization operations and contract manufacturers. He has performed numerous pre-licensing and pre-approval inspections and site visits for licensed biological products. In addition, he has evaluated industry responses both for technical and regulatory merit during FDA regulatory compliance actions and has assessed these responses and offered alternative solutions to resolve technical issues and regulatory concerns.

Reginald was recognized in the 2003 Public Health Achievement Award for his involvement with CBER’s Counter-Bioterrorism (CBT) initiatives for his role as inspection team lead on numerous site visit assessments for facility design, process flow, process validation and aseptic process operations. Reginald has developed and provided training for the FDA Team Biologics and CBER review staff and has trained and certified CBER/OCBQ/DMPQ reviewers. Reginald has served as review committee chair in the review of the Chemistry Manufacturing and Controls (CMC) sections of numerous Biologics License Applications and Supplements for licensed biological products at CBER. He has trained CBER staff on the scientific and regulatory review and evaluation of these applications and supplements.

At Biologics Consulting, Reginald utilizes his depth of experience in CGMP, regulatory affairs, validation, aseptic processing, personnel training and CBT issues to assist clients in the following areas:

  • CGMP evaluation of pharmaceutical facility design, processes and support infrastructure
  • Pre-submission review and support
  • Regulatory strategy development
  • Evaluation of drug substance and drug product production, sterilization, equipment cleaning, personnel monitoring, aseptic processing, lyophilization, quality systems and finishing operations
  • Evaluation, development and assistance with Type C (facility) meeting information for the FDA
  • Third party audits of suppliers and contract manufacturing facilities
  • Evaluation and development of Contract Manufacturing Agreements

Reginald received his BS in Zoology from Howard University in 1977 and attended post-graduate courses in the field of Marine Science/Oceanography from 1978 to 1982.


Education

Graduate Studies, Marine Science, Jackson State University, Jackson, MS (1980-1982)

Graduate Studies, Phycology; Duke University, Beaufort, NC, Marine Research Center, Satellite Campus (1980)

Graduate Studies, Oceanography, Texas A&M University, College Station, TX (1978-1979)

Experiment in International Living, Foreign /Student Exchange Cross-Cultural Experience, Kenya, Africa (Summer 1974)

BS, Zoology, Chemistry minor; Howard University, Washington D.C. (1977)