Overview
NPDK Bioconsulting is a Regulatory CMC and Patent Consulting company aiming to promote the development and commercialization of various biotechnology pharmaceutical products, such as monoclonal antibodies, antibody drug conjugates, therapeutic proteins, cell and gene therapies, and vaccines with ability to support intellectual property covering the products by filing
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, INDs and FDA/EMA meeting packages for international clients, as well as US patent filing and prosecution.
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, INDs and FDA/EMA meeting packages for international clients, as well as US patent filing and prosecution.
Natalia Pripuzova, PhD
Chief Executive Officer, Founder,
Global Regulatory Affairs, CMC
Global Regulatory Affairs, CMC
Our leadership team
Dmitry Kryndushkin, PhD
Co-Founder, US Patent Agent
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 CMC and Intellectual Property protection strategies. We are experienced scientists who can effectively "translate" between the languages of technology and law, creating extra value for our clients' products and helping to implement a step-by-step Go-To-Market strategy.
Our history
