Quality Systems

The BPDF assists university researchers, commercial companies, and not for profit organizations with the development of GMP-compliant manufacturing processes and test methods for early stage biopharmaceuticals, and produces bulk drug substances suitable for non-clinical and Phase I/II clinical trials. The BPDF also produces bulk intermediates for further processing, as well as industrial and agricultural enzymes, following appropriate GMP requirements

We perform the design and optimization of production processes and all GMP manufacturing activities in compliance with the BPDF’s Quality System. The Quality System is designed to meet the requirements of 21CFR210/211, ICH Q5C, Q5D, Q7, Q10 and Q11, as well as applicable Eudralex Rules and compendial standards (USP/NF, Ph.Eur.).

Regulatory Affairs

The BPDF ensures quality and regulatory compliance at all stages of development. We collaborate with clients to develop regulatory strategies, provide submission-ready documentation, and assist with post-submission responses to regulatory bodies.