profilePage

Strategic planer and resourceful regulatory affairs proffesional, offering 13 years of rich experience in the areas of biologics driven therapeutic products  {recombinant proteins, vaccines and biosimilars}.  Skilled in developing regulatory strategies/systems/ cGMP compliance / License applications to regulatory authority { Phase I, II, III and IV } / European CTD / USA BLA / ROW emerging markets / Post approval changes ( National and International), and to obviate the regulatory hurdles during product development phase, commercialization and seek smooth marketing authorization and maintain registrations. 


Specialities: Regulatory Affairs, CTA, CTD, GMP, Legal Compliance, CMC-Biotechno...

�ݺ�ߣ