
NPDK Bioconsulting LLC
NPDK Bioconsulting is a Regulatory CMC and Intellectual Property Consulting company aiming to promote the development and commercialization of various biotechnology pharmaceutical products, such as monoclonal antibodies, antibody drug conjugates, therapeutic proteins, cell and gene therapies, and vaccines through ability to support Regulatory Affairs CMC filings and prosecuting US patent applications.
Dedicated to support of small and medium size international biotechnology companies NPDK Bioconsulting has a deep understanding of RnD, manufacturing, and QA aspects of biotechnology products.
We help in a quick start of interaction with US FDA or EMA on product and process development CMC landscape and can efficiently support clients in their decisions based on the current FDA and EMA requirements.