Transitioning life science research into worldwide products
Overview
NPDK Bioconsulting is a Regulatory CMC and Non-clinical consulting and 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 and pre-clinical 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 and pre-clinical 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
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 of novel 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
As a member of ARM’s Regulatory CMC Forum Natalia contributed to the review article: Invisible but Critical: Managing Process Residuals in Cell Therapies, Alliance for Regenerative Meidicne (ARM) with the chapter: Cell-Specific Process residuals: NK Cells.
These publications 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.
Natalia Pripuzova has 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.
Scientific Publications
At NPDK Bioconsulting, our work extends beyond consulting. We contribute to scientific and regulatory literature that supports the development of novel 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
As a member of ARM’s Regulatory CMC Forum Natalia contributed to the review article: Invisible but Critical: Managing Process Residuals in Cell Therapies, Alliance for Regenerative Meidicne (ARM) with the chapter: Cell-Specific Process residuals: NK Cells.
These publications 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.
Natalia Pripuzova has 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.
Founders and Focus
NPDK Bioconsulting was founded by Natalia Pripuzova, PhD, and Dmitry Kry ndushkin, 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:
NPDK Bioconsulting was founded by Natalia Pripuzova, PhD, and Dmitry Kry ndushkin, 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:
INTERACT, pre-IND, End-of-Phase, and Scientific Advice meetings with U.S. FDA and EMA
CMC Gap Analysis
Regulatory CMC and pre-clinical consulting
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
IP and Regulatory CMC strategies to support various biologics:
Analytical Data Monitoring
Scientific and regulatory writing
- ADCs
- Therapeutic Proteins
- Monoclonal Antibodies
- Non-viral gene delivery (mRNA, exosomes, LNPs, etc.)
- Viral gene delivery (LVVs, AdVs, AAVs, RVs)
- Gene-modified cell therapies
- iPSCs-derived therapies
- Cell and tissue therapies
- CAR-NK and CAR-T cells
- Gene Therapies
- Bispecific Antibodies
In 2025 and 2026 Natalia has participated as a speaker or panelist in multiple events for startups and biotech developers focusing on Cell and Gene Therapies or Biotechnology products. The access to video recording of selected Presentations and slides is provided here.
Client Support
We work with small and mid-sized biotech companies developing innovative biologics and cell therapies.
Our services include:
We work with small and mid-sized biotech companies developing innovative biologics and cell therapies.
Our services include: