Meet Our Team
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ClinReg Partners bring over 25 years of combined extensive experience in the Oncology, Respiratory, Cardiovascular, Dermatology, Ophthalmology, and many more therapeutic areas. We will partner with you throughout your drug's journey from cradle to grave. By performing a through gap analysis, we will help you plan your label and Target product profile, performing competitive analysis of your desired outcome and similar products in the market, design your protocol with endpoints that not only it will lead you to a successful clinical study but a successful regulatory submission.
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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 keep the end in mind.
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The final outcome of conducting clinical research, spending millions of dollars is to have one important piece of paper in hand called "USPI" United States Prescribing Information for US, or similar globally. We guide you, keeping the end in mind, when helping you design your protocol.
Example of Experiences:
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Our team of consultants have extensive experience in:
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Drug, device, biologics, combination, cosmetic, OTC drug development.
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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.
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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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​ Bani Tchekanova, MS, PhD,
Chief Principal Advisor, Global Regulatory Affairs
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Schedule your free Advisory Session with Dr. bani
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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, combination, 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 eCTD compliant IND, NDA and BLA preparations and submissions. Dr. Tchekanova led executive level positions at ABBOTT, BOEHRINGER, EMD SERONO, ARTEMIS, PAREXEL, COLLIDION, and HUYABIO International. Dr. Tchekanova has worked extensively with the US FDA, PMDA, EMEA, and Health Canada. She has recently been appointed by the FDA as a member of the FDA Advisory Committee for the 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.
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