Dr. Bani
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, and HUYABIO International.
Passion to help Pharmaceutical and Drug Develop companies to navigate the ever-changing world of clinical and regulatory landscape. Advising and working with Executives to bring promising products into the market as quickly as possible ensuring regulations compliance, in order to help patients in need who may not have any other option available to them.
Focused Areas
Over 25 years of experience in Regulatory Affairs, Quality Assurance, and Clinical Research with a proven track record of executing global strategy techniques in a timely and cost efficient manner, from discovery to post marketing surveillance activities.
Working with many small to large companies, consulting on the US FDA, and EU Competent Authorities Marketing authorization process.
Providing clinical research advise and regulatory strategy for successful IND, CTA, and NDA applications.
Experience in many different therapeutic areas such as oncology, cardiovascular, dermatology, gastroenterology, orthopedic, and more.
Special Areas of Expertise
Dr. Bani providing advising on a wide range of expertise, including:
Review and assessment of your current Clinical Regulatory Strategy.
Gap analysis and strategic advice to ensure compliance, submissions such as IND and NDA.
Advising in the development of clinical protocol to comply with regulatory requirements.
Provide key advice on strategies to interface with Regulatory Agencies such as FDA
Members of
