Dr. Vinay Kumar Email & Phone Number

India

Delhi-Ncr

Vast Experience in drafting/authoring of following documents: Respond to the queries raised by the various regulatory authorities such as USFDA, MHRA, EMA, SAHPRA, etc. Preparation of IB, Protocol, and other study related documents Preparation of patient safety narratives of adverse events observed in clinical study Preparation of pre-clinical sections of the marketing authorization dossier (Module 2.4 and 2.6) Preparation of clinical sections (Clinical Evaluation Report) of the marketing authorization dossier (Module 2.5 and 2.7) Determination of PDE/OEL of pharmaceuticals, chemicals and impurities Preparation of the informative texts (SmPC, PIL, PI) of the marketing authorization dossier Preparation of preclinical and clinical expert statements Release the document after final QC to various health authorities Prepare and review the various WIs/SOPs which are needed by the department timely to update the standards

Ghaziabad, Uttar Pradesh, India

New Delhi, India

Currently involved in Preparation of CTD (common technical document) non-clinical pharmacology-toxicology overview, clinical overview for IND and NDA filing. Regulatory agency queries and recommend appropriate strategies to resolve the issues pertaining to toxicology, health and environmental risk assessment of generic and differentiated products. Toxicological evaluation of impurities: monitor and review studies and or qualify impurities based on available literature.Health hazard and risk assessment of pharmaceuticals and cosmetics. Establish PDE (permitted daily exposure) and acceptable levels for pharmaceuticals, excipients and impurities. Toxicological review of OEL (occupational exposure limit) monographs for pharmaceuticals. Environmental risk assessment of pharmaceuticals.