BioPharmaceutical Quality Solutions




Dr. John Geigert has over 45 years experience working with biopharmaceutical Chemistry, Manufacturing & Control (CMC) regulatory compliance strategies. 

Biopharmaceutical Companies: Over 20 years, John demonstrated successful CMC leadership for moving six biopharmaceuticals (recombinant IFN-beta, IL-2, GM-CSF and TNFR; chimeric Rituxan and murine yttrium-90 labeled Zevalin monoclonal antibodies) from clinic into market approval with both the FDA and EMA; served for 10 years as Vice President of Quality & CMC Regulatory Compliance (at both Immunex and IDEC Pharmaceuticals).  
Independent Consultant: For 25 years, John has consulted on biopharmaceutical CMC regulatory compliance strategy, with both startup and established biopharmaceutical companies, both for clinical development strategies and for postmarket approval commercial biopharmaceuticals.  He has consulted on recombinant proteins, monoclonal antibodies, fusion proteins, bispecific antibodies, antibody drug conjugates (ADCs), and now cellular and gene therapy medicines. John is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professionals Society (RAPS) Certification Board; and past chair of the PDA Biopharmaceutical Advisory Board. 
Expert in CMC Regulatory Compliance for Biopharmaceuticals: John is the author of the book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, now in its 4th Edition, Springer Publishing.  He has written articles for the Regulatory Affairs Professional Society (RAPS) Regulatory Focus including a 4-part series on What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products and a 4-part series on Demystifying CMC Regulatory Strategy for Biologics.  He is also guest lecturer for PDA Europe, the University of Southern California (Pasadena) and the Danish Atrium Regulatory Science programs.
Dr. Geigert specializes in developing risk-managed, cost-effective biopharmaceutical CMC regulatory compliant strategies, from clinical development through market approval for recombinant proteins, monclonal antibodies, biosimilars, and gene therapies. He continues to perform CMC strategy gap analyses, evaluation of product comparability plans, and CMC due diligence audits for product/ company acquisitions/ mergers. John also presents on-site tailored CMC regulatory compliance courses for biopharmaceutical companies - both protein-based and cell & gene therapy-based.
John can be contacted at or +1-760-525-5154