We also offer intellectual property services by supporting US patent application filing and prosecution related to biotechnology innovations.
Dedicated to assisting small and mid-sized 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.
Our services include strategic CMC regulatory consultation, regulatory authoring, and submissions for Pre-IND (PIND), IND/IMPD, and BLA/MAA applications.
We also provide regulatory guidance and author briefing packages for FDA and EMA meetings, ensuring alignment with evolving global standards. Additionally, we offer expert assistance in intellectual property protection through U.S. patent strategy 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.
