BioDev Consulting LLC
BioDev Consulting LLC is an independent consulting firm located in the San Francisco Bay Area. We have nearly 30 years of research and pharmaceutical development experience working globally in big pharma, start-up and virtual biotechs. We offer biopharmaceutical development and regulatory CMC expertise to step in and direct your CMC programs from inception or at any phase in the development cycle as part of a virtual or established corporate environment. We are GMP trained and familiar with the hurdles of moving various peptide, protein and antibody compounds through pre-clinical development and manufacturing to deliver your drug product to the clinic. Whatever it takes to move your biologic research program into the clinic and through the proof of concept stage and on to advanced clinical trials, we are here to support your program or company.
BioDev Consulting has significant experience identifying and managing outsourced contract manufacturing and research organizations (CMO, CRO) that cover the following development support services:
- Synthetic Peptide API
- Protein and Antibody API
- Analytical Methods Development
- Product Characterization
- Pre-Formulation
- Clinical Formulation
- Fill/Finish/Labeling
- Release Testing
- ICH Stability Studies (design, implement and monitor)
We offer independent strategic review of current program data and can recommend a path forward. We can also help identify a suitable compound molecule among many candidates to move into drug development.