TEAM of Experts
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.
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Expert Team Ready to Support Your projects:
- CMC Expert, Clinical Expert, Project Manager, Global labeling Expert, Non-Clinical Expert
Our advisors will work with you throughout your clinical trials process, having the end in mind, when designing your clinical protocols. We will help you in every step of the way, develop your Target Product Profile so that your study design will achieve the desired outcome. It is critical to keep the end in mind and work from the desired label.
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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 in US. It is critical to keep USPI in mind when designing your clinical studies. Knowing the desired indication, target 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.
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 a 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.