NPDK Bioconsulting, Regulatory Affairs CMC and Patent Consulting

NPDK Bioconsulting is a Regulatory CMC consulting and regulatory writing firm specializing in the development, compliance, and FDA regulatory support for a broad range of biotechnology and biopharmaceutical products, including cell and gene therapies (CAR-NK, CAR-T, viral vector-based), monoclonal antibodies, antibody-drug conjugates (ADCs), therapeutic proteins, vaccines, and any new therapeutic modalities. We also offer intellectual property services by supporting US patent application filing and prosecution related to biotechnology innovations.

Dedicated to assisting small and mid-size international biotechnology companies, NPDK Bioconsulting brings deep expertise across R&D, GMP manufacturing, quality assurance (QA), and global regulatory requirements. We help clients initiate early engagement with the US FDA, efficiently navigating the product and process development CMC landscape, and aligning development programs with current FDA and EMA regulatory frameworks.

To learn more about NPDK Bioconsulting services please visit: https://npdkbio.com/

Our services include strategic CMC regulatory consultation, regulatory authoring, and submissions for Pre-IND (PIND), IND/IMPD, and BLA/MAA applications. We provide regulatory guidance and author briefing packages for FDA and EMA meetings, ensuring alignment with evolving global standards. Meet our Regulatory Affairs team: Natalia Pripuzova, PhD

Additionally, we offer expert assistance in intellectual property protection through U.S. patent strategy and prosecution. Meet our IP Counselling team: Dmitry Kryndushkin, PhD

If you require highly qualified and affordable Regulatory Affairs CMC or Intellectual Property Law services, please contact us to discuss your needs: natalia.pripuzova@npdkbio.com