Independent Consulting Focus:

1. Provide technical & regulatory advice on chemistry, manufacturing and control (CMC) technologies for all phases of biotech and vaccine product development from non-clinical through Phase I, II, III and Biological License Application (BLA) submission.
2. Review and provide advice on the science, manufacturing technology and regulatory issues for assessments by emerging biotech companies & venture capital firms for business development decisions on a variety of vaccine technologies.
3. Provide CMC advice for Pre-IND meetings, IND submissions, End-of-Phase 2 (EOP2) meetings and BLA submissions for biotech and vaccine products.
4. Provide review and advice on the design of Phase I/II and commercial production facilities for biotech and vaccine products.
5. Provide technical and business management assistance for the evaluation and selection Contract Manufacturing Organizations (CMOs) by clients and provide technical and project management assistance for technology transfer, process and analytical assay development and production of clinical trial materials by CMOs.

Call him at 919-630-5199