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.

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 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:

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:

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

Natalia has participated in an expert Panel at the Cell Therapy & CMC Manufacturing Forum in San Diego, CA organized by Open Biopharma Research and Training Institute for the open discussion on From Complete Response (CR) Letter to Commercial Reality: Rethinking CMC Reediness

Client Support

We work with small and mid-sized biotech companies developing innovative biologics and cell therapies.

Our services include: