NPDK Bioconsulting

NPDK Bioconsulting is a specialized regulatory and intellectual property consulting firm that assists biotechnology and pharmaceutical companies in navigating the complex regulatory landscapes of the US FDA and EMA. The firm provides strategic guidance on Chemistry, Manufacturing, and Controls (CMC), regulatory writing, and global submission pathways for advanced therapeutic modalities. Founded by former FDA reviewers and industry leaders, NPDK focuses heavily on emerging technologies such as allogeneic cell therapies (CAR-NK, CAR-T), monoclonal antibodies, and antibody-drug conjugates (ADCs). They provide end-to-end support from early-stage R&D through to BLA/MAA submissions and post-approval supplements, including expert IP protection and patent strategy.