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 on product and process development CMC landscape and can efficiently support clients in their decisions based on the current FDA and EMA requirements.
We are deeply involved in CMC regulatory strategizing and authoring of PINDs, IND/IMPD, BLA/MAA and FDA/EMA meeting packages for international clients, as well as US patent filing and prosecution.
Global Regulatory Affairs, CMC
NPDK Bioconsulting was founded by Natalia Pripuzova, PhD and Dmitry Kryndushkin, PhD to support companies to secure their competitive advantage in U.S. and global markets by assisting in developing Regulatory Affairs Chemistry Manufacturing and Control (CMC) and Intellectual Property (IP) Law protection strategies. The founders are experienced regulatory scientists who can effectively "translate” the languages of technology, regulatory science and law, creating extra value for our clients' products and implementing step-by-step Go-To-Clinic and Go-To-Market strategies.
We are active members of the leading organizations in life sciences, biotechnology, and professional development:
- Parenteral Drug Association (PDA)
- Alliance for Regenerative Medicine (ARM)
- Orange County Regulatory Affairs – Discussion Group (OCRA-DG)
- Women In Bio (WIB)
At NPDK Bioconsulting, our work extends beyond consulting. We’ve being involved in creation of scientific publications including a recent book chapter in the Current Topics in iPSCs Technology, where Natalia served as a Corresponding Author: Proteomic Approach for Creation of the Protein Marker Panels to Control the Quality of Human iPCS
We’ve been invited speakers and panelists at key industry events, sharing insights on regulatory innovation and next-generation manufacturing. These engagements reflect not only our technical expertise but also our commitment to shaping the future of advanced therapies.
Dmitry has been featured as a Speaker and Panelist at Center Force IP Strategy Summit: Biotech & Pharma – Boston.
Center Force IP Strategy Summit: Biotech & Pharma – Boston
Natalia’s Regulatory CMC expert opinion was recently featured on Alpha Sense Platform with opinion interview on Challenges in Development and Manufacturing of Natural Killer Cell Therapies.
If you’re looking for a partner who combines scientific depth with strategic clarity — we would love to hear from you.
