Meet Our Team

ClinReg Partners bring over 25 years of combined extensive experience in the Oncology, Respiratory, Cardiovascular, Dermatology, and many more therapeutic areas with global Regulatory Affairs, Strategic Quality Assurance and Clinical Research experience. Our goal is to help you design your protocol in such a way that not only it will lead you to a successful clinical study but a successful regulatory submission.

Our consultants will work with you, having the end in mind, when designing your clinical protocols. We will help you in every step of the way to design your Target Product Profile so that your study design will achieve the desired outcome. It is critical to work backward from the the desired label.

The final outcome of all these years of conducting clinical research, spending millions of dollars is to have one important piece of paper in hand called "USPI" United States Prescribing Information. It is critical to keep USPI in mind when designing your clinical studies. Knowing what will be the desired indication, safety profile, patient population, etc. at the beginning of your phase I studies, is critical to success of your product. Our team of experts will guide you to achieve that.

Example of Experiences:

Our team of consultants have extensive experience in:

Drug, device, biologics, cosmetic, OTC drug development.
Wide range of experiences from small to large pharma, consulting, clinical research monitoring, vendor management, ICF and protocol development, eCRF, SOP development, IND, NDA, 510K, PMA, advertising and promotion.
Training of principle investigators, strategy development, publishing, submission and management of in development and marketed products.

Our expert consultants can guide you throughout the life span of your product.

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Spotlight on Bani Tchekanova, MS, PhD,

Chief Principal Advisor, Global Regulatory Affairs

ClinReg Partners, LLC LinkedIn

Schedule your free Advisory Session with Dr. bani

Dr. Tchekanova has extensive experience in the oncology and cardiovascular therapeutic areas as global Regulatory Affairs, Strategic Quality Assurance and Clinical Research leads. With over 25 years of experience, she has been Senior Vice President of Global Regulatory Affairs, Vice President of Quality and Clinical Operations, Global Labeling Lead, and more.
Dr. Tchekanova has been part of large, small, and consulting companies learning and teaching from A to Z of drug development. Throughout her career, she has worked on drugs, devices, cosmetics, and over the counter drugs. She has put together the fundamentals of labeling operations and clinical operations in her past careers. Dr. Tchekanova has worked on many INDs and NDAs and has guided many teams on eCTD development of IND, NDA and BLA preparations and submissions. Dr. Tchekanova led executive level positions at ABBOTT, BOEHRINGER, EMD SERONO, ARTEMIS, PAREXEL, COLLIDION, HUYABIO International. Dr. Tchekanova has worked extensively with the US FDA, PMDA and EMEA. She has recently been appointed by the FDA as a member of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. Dr. Tchekanova received her PhD in Molecular Biology and Health Care Administration, MS in Clinical Laboratory Sciences and a BS in Biology and Chemistry from University of Wisconsin-Milwaukee.” Recently appointed as a member of FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology.