11^th European Biosimilars Congress

Kamali Chance has a PhD in Nutrition/Nutritional Biochemistry, Master’s in Public Health and Regulatory Affairs Certification from Regulatory Affairs Professional Society. She is the CEO & Executive Consultant of KC Biopharma Consulting, LLC, USA. She has an extensive regulatory strategy/ regulatory affairs experience working at a Clinical Research Organization and for pharmaceutical and biotechnology companies. She advises pharmaceutical and biotechnology companies in the development of region specific and/or global regulatory strategy for the development of biosimilars/biologics/drugs. She has authored/co-authored numerous articles on the development of biosimilars and small molecule drugs. Her work experience includes strategic regulatory planning including clinical development plans, preparing and submitting meeting requests to regulators, guiding the client through meeting preparations and attendance at FDA/EMA meetings, regulatory submissions including IND and IND maintenance, ANDA/NDA/BLA/MAA preparations and submissions. She is proficient in performing due diligence assessments for investments and acquisitions for biopharmaceutical/pharmaceutical products.