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Journal of Bioequivalence & Bioavailability

Ashish Shedage

Ashish Shedage

Department of Clinical and Bioequivalence Research, Cipla Limited, R &D, Center, LBS Marg, Vikhroli (W), Mumbai 400 083, India

Biography
Cipla Limited · Regulatory medical writing- CRD 14 years of experience in Regulatory medical writing, Global labeling, Pharmacovigilance, Agreegate safety report like PBRER, DSUR, Clinical trials writing,eTMF, BA/BE, Pre-clinical DMPK. Responsible for medical writing and sign off in support of product registration and life cycle globally. Well oriented with CTD guidelines, Global labeling guidelines, Pharmacovigilance guidelines, Aggregate Safety reporting.