Balbir Negi

Background

About Balbir Negi

Total work experience of 30+ years in Formulation and 15 years from APIs-Ranbaxy labs Ltd. PROFESSIONAL DETAILS:Masters Science Chemistry Hemwati Nandan Bahuguna Garhwal University 1990Masters in Business Management Project Management from Sikkim Manipal University in 2011Audit Faced:US FDA,TGA,MHRA, Colombia-Invima GMP, COPP WHO GMP,Kenya,tender,Yemen, Tanzania. EXPERTISE: New Project Erection and Commission. Quality Assurance -handling QMS documentation and audit face.Quality assurance - IPQA checks,SOP, qualification, calibration and validation, APQR, MFR, BPR,Record storage, safety manual, quality manual, VMP, SMF, recall, market complaint and CAPA.Quality Control - Stability studies, AMV, STP, STS, Release of product. COA,Calibration,qualification, validation,control samples, OOS, OOT and analyst validation. Regulatory Affairs- handling state FDA,CDSCO and other countries,CRO Clinical Trial,state FDA and CDSCO – DCGI for Product Permission, Form -25, Form -28, form-29/30, Schedule M GMP,COPP WHOGMP, Form -44 New Drug, Form -11/12,Form-40/41 – Import registration,FDC NOC, NCC,LVP approval, Cosmetic products, Herbal plant approval FSSAI online product filing.DPCO, Artwork approval for domestic and export.Dossier/DMF preparation & review in ACTD, CTD regulatory dossiers for ASEAN CIS, Latin American,ROW & African Countries. registration of pharmaceutical products country specific and their queries reply.Regulatory submission in Central Drugs Standard Control Organization (CDSCO)-India for new drug application/global clinical trial/EC submission /SAE (serious adverse events)/Nutraceutical clinical trial/ product registration(human/Veterinary /food as drug)/ food additive NOC/import/export & T License,Review of documents for regulatory submissions Trial master file, Site master file, Case report file and regulatory dossier. Erection and Commission of formulation and API plantsProject handle – Beta Lactam / Distillation unit – API, Formulation -SVP, LVP, Tablet, Capsule, Ointment, Liquid, Dry syrup Veterinary,Herbal, Cosmetic,Aerosol,Liquid disinfectant and pellets.