Strategic Regulatory Consulting
East Bay Bio will provide a leadership role in advising or leading drug/biologic development teams on regulatory interactions with authorities. Dr. Fritsch will provide regulatory options and development pathways for moving your project forward.
Dr. Fritsch, President of East Bay Bio has a well-developed ability to lead organizational teams in the planning of regulatory interactions. She is adept at managing teams preparing for regulatory submissions, meetings and in the general development of drugs and biologics. She has lead teams in BLA/NDA filings and has written and filed numerous INDs, BLAs and designation submissions.
Due Diligence Support
Whether the client is interested in acquiring a product, or company, East Bay Bio can support the due diligence process by reviewing documents and providing independent advice based on more than 30 years of experience in the biopharmaceutical industry.
Dr. Fritsch will provide a critical review of documents planned for regulatory submissions. Should a client need a review or generation of an IND, BLA, Type A, B or C meeting package or a designation submission, East Bay Bio, can provide assistance.
Regulatory Meeting Planning
East Bay Bio will help facilitate preparation for, and requesting/managing regulatory meetings.