Prashant Patel

Background

About Prashant Patel

Post graduate in Pharmaceutical Analysis [MS (Pharm)] from National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad and Graduate (B. Pharm.) from Gujarat University. A regulatory professional with an experience of more than 2.5 years at Biocon Ltd, Bangalore. Effectively handled Pre-Clinical, Clinical and Registration related activities w.r.t Biologicals (Novel and Biosimilar) and Small Molecule with Approval Authority (RCGM & DCG (I)). Submission of response to Queries/Deficiencies raised by Regulatory Authorities within timeline Updating of all regulatory guidelines and preparation of checklist for ease of dossier compilation as per trend analysis. Well versed with ICH guidelines and Familiar with USFDA and EMEA guidelines for biological/ biosimilar/combination products Specialties: •Regulatory Strategy Planning and implementation •USDMF, ASMF, CEP and ANDA •RCGM :(IBSC Registration, Import, Export, Transfer and Receive of GMO, Activities Involving Research, Production, Preclinical and other Studies applications) •DCG(I):(Dossier preparation for Clinical trial (Phase and marketing authorization applications as per CTD Modules) for Biologicals and small molecules Registration of overseas product in India, BA/BE, Import/ Manufacturing Test license, Import/export NOC and Post approvals applications •Design of Experiments (statistical analysis) •Strong analytical skills, Self-motivated, result oriented professional with Team Leadership activity •An effective communicator •Excellent relationship building & interpersonal skills.