Hemant Parmar Email and Phone Number

Key job responsibilities are documents followed by below:1). Literature search from various sources like regulatory site (USFDA, HC, EMA & TGA etc.), Cochrane, PubMed, Google Scholar, Sci-Hub, Embase, Clinical trial government.org, etc2). Module writing 2.4, 2.5, 2.6 & 2.7 ( Based on literature search through articles and database search), Nonclinical Study Report, Manuscript writing 3). Clinical Study Protocol/ Clinical Investigation Plan /Clinical Investigation Report/Clinical Study Report/Investigation Brochure/Patient Diary Card/Patient Scale & Various protocol writing.4). Query related to Biosimilars & Generic drugs preparation ( Documents which are preparing like CSP and CSR checklist).5) Learned deeply the guidelines like ICH E3/E6 and ISO 141556). Synopsis writing for Excel and Word both the types of CSP preparation

Development consultant and scientific affairs 1). Performing exhaustive literature search and scientific data extraction from various regulatory database such as USFDA, ECHA, RIFM, NICNAS, EMA, EFSA, USEPA, TGA, UKPAR, Health Canada and other regions.2). Interpreting toxicological data and Point of Departure (POD) to develop formulation’s high-quality safety profile. 3). Integrating and summarizing data for human toxicity endpoints such as DART, genotoxicity, carcinogenicity etc.4). Preparation of various nonclinical and clinical module writing like; PDE/OEL document, extractable and leachable, medical device related toxicological documents, SDS & MSDS Sheets and various other preclinical/toxicology documents preparation.5). Experience of module 2.4 Nonclinical overview and 2.6 summary writing. Received training on 2.5 and 2.7 modules writing and have clear understanding of it.6). Documents compilation as per the norms of ICH and OCED regulatory guidelines.7). Understanding of F value calculation and preparation8). Basic knowledge of ISO 10993-1 of medical devices "Biological Evaluation of medical devices" as per USFDA guidelines.9) Basic knowledge of Cosmetic Products Safety Report through training Other experience & Webinar:> AI-Based Hepatotoxicity Assessment and Digital Peer Review from AIRA matrix> Supporting accurate and cost-effectivecarcinogenicity risk assessment, As genotoxicity risk assessment Webinar by LHASA>Critical needs for moving towards an animal-free regulatory system for testing chemicals workshop by ECHA

Participation in National Toxicology Centre studies at NIPER SAS Nagar: Repeated dose, Reproductive toxicity, carcinogenicity & Genotoxicity study.1).Indulged in necropsy and dissection of animal during toxicological study. 2). Observed target organs effects & derived NOAEL/LOAEL, NOEL/LOEL effects.3). Performed biochemical, histopathology & body & organ weight of animals for toxicological study.4). Performed euthanasia technical like; Cervical dislocation, decapitation and CO2 chamber in toxicological study5). Learned instrumentation part of NTC like; autostainer, HPLC, UV, Multiplat reader, Microscope, Tissue processor.6). In silico tool experience: Chimaera, Maestro, Toxtree, and Chemdraw tools, which are used for molecular docking, mutagenicity, and structural activity identification

Quality assurance and Quality Control, animal handling, Good Document Practice, SOP training

Quality assurance and Quality Control, animal handling

Manufacturing, Quality Assurance, Research & Development, Quality Control and Production1). Quality Control test for hormonal tablets: Weight variation, Drug content, Disintegration & Dissolution tests, thickness, hardness, friability.2). Quality Assurance: Master Formula Record, Batch Manufacturing Record, SOP development, GDP/GMP compliance, QMS, Quality Inspection training 3). Production: Tablet punching machine, Packaging, Storages, Mixing & processing for tablet development process observation.Received placement offer from Unicure Remidies as QA associate.