Drug Biotechnology Development

We are a comprehensive consortium of experienced clinicians, pharmaceutical scientists, regulatory strategists & business development experts that provide product & business development assistance & solutions for the pharmaceutical, biotech, medical product & related industries. From project conception to product launch, we provide a focused approa... ch to the pharmaceutical & clinical development of drugs, devices & biologics for regulatory submissions. We have extensive experience with all phases of product development, including pre-clinical, clinical (Phase I-IV), CMC (analysis, formulations, process, production), outsourcing, CRO oversight and regulatory interactions, document preparation, review and filings. Our clients range from the major multinational pharmaceutical companies to small start-up ventures and span all the continents of the globe. Over the past several years, D&BD has successfully assisted clients with: Regulatory Interactions Pre-IND Meeting Submissions and Meetings IND Submissions End of Phase 2 Meetings ANDA, NDA, BLA, PMA and 510K SubmissionsRead More