Transitioning life science research into worldwide products
Overview
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-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.
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.
Our Firm's Story
Founders and Focus
NPDK Bioconsulting was founded by Natalia Pripuzova, PhD, and Dmitry Kryndushkin, PhD to support companies in securing a competitive advantage in U.S. and global markets. We assist in developing Regulatory Affairs, Chemistry, Manufacturing and Control (CMC) strategies, and Intellectual Property (IP) protection for biopharmaceutical products including monoclonal antibodies, cell and gene therapies, therapeutic proteins, ADCs, and vaccines.
As experienced regulatory scientists, we specialize in helping clients navigate the complexities of FDA and EMA regulatory expectations, regulatory writing, and global submission pathways. We help translate the languages of science, regulation, and law to create added value for our clients and build clear Go-To-Clinic and Go-To-Market plans grounded in current regulatory CMC guidance.
Memberships
We are active members of leading organizations in life sciences, biotechnology, and professional development:
These memberships help us stay informed on evolving trends in biotech regulation, advanced therapy product development, and regulatory policy.
Scientific Publications
At NPDK Bioconsulting, our work extends beyond consulting. We contribute to scientific and regulatory literature that supports the development ofnovel biologics and cell-based products. Natalia Pripuzova served as a Corresponding Author on a book chapter in Current Topics in iPSC Technology:
Proteomic Approach for Creation of the Protein Marker Panels to Control the Quality of Human iPCS
This publication highlights our expertise in CMC quality attributes, analytical quality control methods, and product characterization methods for cell therapy regulatory submissions.
Speaking Engagements
We are invited speakers and panelists at key industry events, sharing insights on regulatory CMC innovation, FDA documentation, and biotech manufacturing strategies.
Dmitry Kryndushkin has been featured as a speaker and panelist at the Center Force IP Strategy Summit: Biotech & Pharma – Boston, where he joined industry leaders to discuss intersections between IP strategy and regulatory frameworks for biologics. His session addressed practical considerations for navigating IP protection in the context of protein-based therapeutics, including the scientific challenges of characterizing complex biologics, managing aggregation risks, and ensuring data generated for regulatory submissions can support robust patent claims. The panel also explored how cross-disciplinary coordination between scientific, legal, and regulatory teams can shape successful IP positioning during product development.
Natalia Pripuzova recently shared her CMC regulatory perspective on Alpha Sense Platform, with an expert interview focused on the development and manufacturing challenges of Natural Killer (NK) Cell Therapies, including FDA regulatory pathways, CMC documentation, and clinical readiness.
Natalia was invited as a speaker and panelist at the 2025 Orange County Regulatory Affairs – Discussion Group Fall Symposium with a talk on: Navigating Regulatory Expectations and the Complexity of Control Strategy in Allogeneic Cell and Gene Therapies.
Client Support
We work with small and mid-sized biotech companies developing innovative biologics and cell therapies. Our services include:
NPDK Bioconsulting was founded by Natalia Pripuzova, PhD, and Dmitry Kryndushkin, PhD to support companies in securing a competitive advantage in U.S. and global markets. We assist in developing Regulatory Affairs, Chemistry, Manufacturing and Control (CMC) strategies, and Intellectual Property (IP) protection for biopharmaceutical products including monoclonal antibodies, cell and gene therapies, therapeutic proteins, ADCs, and vaccines.
As experienced regulatory scientists, we specialize in helping clients navigate the complexities of FDA and EMA regulatory expectations, regulatory writing, and global submission pathways. We help translate the languages of science, regulation, and law to create added value for our clients and build clear Go-To-Clinic and Go-To-Market plans grounded in current regulatory CMC guidance.
Memberships
We are active members of 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)
- Pharmaceutical & BioScience Society International (PBSS)
These memberships help us stay informed on evolving trends in biotech regulation, advanced therapy product development, and regulatory policy.
Scientific Publications
At NPDK Bioconsulting, our work extends beyond consulting. We contribute to scientific and regulatory literature that supports the development ofnovel biologics and cell-based products. Natalia Pripuzova served as a Corresponding Author on a book chapter in Current Topics in iPSC Technology:
Proteomic Approach for Creation of the Protein Marker Panels to Control the Quality of Human iPCS
This publication highlights our expertise in CMC quality attributes, analytical quality control methods, and product characterization methods for cell therapy regulatory submissions.
Speaking Engagements
We are invited speakers and panelists at key industry events, sharing insights on regulatory CMC innovation, FDA documentation, and biotech manufacturing strategies.
Dmitry Kryndushkin has been featured as a speaker and panelist at the Center Force IP Strategy Summit: Biotech & Pharma – Boston, where he joined industry leaders to discuss intersections between IP strategy and regulatory frameworks for biologics. His session addressed practical considerations for navigating IP protection in the context of protein-based therapeutics, including the scientific challenges of characterizing complex biologics, managing aggregation risks, and ensuring data generated for regulatory submissions can support robust patent claims. The panel also explored how cross-disciplinary coordination between scientific, legal, and regulatory teams can shape successful IP positioning during product development.
Natalia Pripuzova recently shared her CMC regulatory perspective on Alpha Sense Platform, with an expert interview focused on the development and manufacturing challenges of Natural Killer (NK) Cell Therapies, including FDA regulatory pathways, CMC documentation, and clinical readiness.
Natalia was invited as a speaker and panelist at the 2025 Orange County Regulatory Affairs – Discussion Group Fall Symposium with a talk on: Navigating Regulatory Expectations and the Complexity of Control Strategy in Allogeneic Cell and Gene Therapies.
Client Support
We work with small and mid-sized biotech companies developing innovative biologics and cell therapies. Our services include:
- Regulatory CMC consulting
- CMC Gap Analysis
- INTERACT, pre-IND, End-of-Phase, and Scientific Advice meetings with U.S. FDA and EMA
- IND, IMPD, BLA and MAA authoring
- Regulatory Trackers and Templates (custom per specific product type)
- Collaborative Registration Procedure (WHO reliance pathway)
- Navigating through country-specific submissions in Russian speaking countries
- Scientific and regulatory writing
- Analytical Data Monitoring
- IP and Regulatory CMC strategies to support for various biologics:
- Cell and tissue therapies
- iPSCs-derived therapies
- Gene-modified cell therapies
