Speakers

Darshan Aigal is a Director of the Global Complex Generic Regulatory Affairs in Cipla Ltd. Darshan has Post Graduate (in Organic chemistry) at Mumbai university before starting his carrier in Pharmaceutical Industry. Also, he has a P.G.D.M degree in business Management from NMIMS, Mumbai University. He is also a “Six Sigma” green belt certified.    For almost 21 years, he has worked in the Pharmaceutical Industry in various areas such as Regulatory Affairs and Analytical development.  He has broad base of experience in registration of Complex generics drug product & drug substances including Polymers, Peptides, biocatalyst process, premix and Co-crystal, as per current regulatory expectations across all markets (US, Eu, Brazil, Australia, China, etc.).

In Cipla, he is currently responsible for overall global registration of complex generic drug product. Prior to his current role, he has also worked as Global API regulatory with handling of 200+API. He was also a Scientist in analytical development. In Cipla, he has significantly contributed to the regulatory capabilities of complex generics drug product (Peptide & oligonucleotide) & also involves in his previous role for regulatory filing of complex APIs including continuous flow technology and polymer.