
PRAVIN KHARAT
Study personnel

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Skills
Clinical trialsIch gcpPharmacovigilancePharmaceuticsRegulatory affairsGlpPharmacologyClinical developmentSopFormulationLife sciencesPharmaceutical industryToxicologyIndResearch and developmentHigh performance liquid chromatographyGood clinical practiceGood laboratory practiceStandard operating procedurePreclinicalDrug testingAnalysisDocumentationArchivingClinical pharmacologyLaboratory animalEfficacyAdverse eventsDrug safety data sheetMsdsOecdReachAbout me
A strategist cum implementer with recognized proficiency in spearheading operations in the areas of toxicity studies of pharmaceutical, biotechnological, agrochemicals and cosmetic products with an aim to accomplish corporate plans and goals successfully, proficient in leading dedicated teams for running successful operations of regulatory toxicology for business excellence, excellent relationship building, interpersonal skills, strong problem solving and organizational abilities. Specialties: Risk Assessment of Cosmetics/Personal care products and Chemicals Expertise in working together with Toxicology and pre-clinical team. Preparing formats and Standard Operating Procedures (SOPs). Preparing, Reviewing and evaluating study protocols and reports of non-clinical studies. Designing, conducting and monitoring different types of non-clinical studies for regulatory as well as non-regulatory purposes. Experience in development of various types of animal models.
Education

K.M.Kundnani college of pharmacy
2010 - 2012Master's Degree Pharmacology and Toxicology AMaster in Pharmacy in Pharmacology and Toxicology department
Experience

SA-FORD
Sept 2012 - Jun 2013Study personnelTesting of test item and agrochemical products on Rodents in Toxicology department as per schedule ‘Y’, OECD, EU and ICH Guidelines.1. Well knowledge about “Good Laboratory Practice” (GLP), Schedule ‘Y’, OECD, EU and ICH Guidelines.2. Good handling and Dosing practice in Rodents.3. Good Knowledge of Dose Calculations and Drug Formulation preparation.4. Good practice of various blood collection methods5. Worked in following studies:• Acute oral toxicity test in Rats• Acute Inhalation induce toxicity testing in Rat• Acute dermal irritation test in Rat• Skin sensitization and maximization test in Guinea pigs• Acute Eye and Dermal irritation test in Rabbit6. Involve in the Preparation of:• Documentation of study related data• Study plan and Final report preparation• Archiving of Raw data Files.• Chemical Utilization and Log Books record maintaining Show less

Bharat Serum and Vaccines LTD
Jun 2013 - Nov 2015Research Officer in Preclinical and Toxicology Department (R&D)1. Preclinical and Toxicological testing of New Drug On Laboratory animals as per Schedule ‘Y’, OECD, EU, SCCS and ICH guidelines.o Conducted and monitored Pharmacokinetic, Biodistribution studies of various drug formulation in rodentso Standardized and monitored efficacy, In vivo release studies for different oncology products in ratso Immunization Study in Rodentso Standardized, designed and monitored acute, sub-acute, sub chronic and chronic toxicity studies on rodents and non-rodentso Pyrogen test in rabbits2. Handled Hematology and clinical chemistry analyzers3. known operation of various Statistical analysis software: • Probit Analysis for LD50 calculations• PK solutions Pharmacokinetic Data Analysis Version 2.0• Graph pad Prisms version 5 for statistical analysis 4. Well known about Interpretation of results, final report preparation and proper Documentation of study related data.5. Standardized formats and SOPs. Show less

Intertek india pvt ltd
Jan 2015 - Jan 2016Toxicologist
Intertek
Jan 2015 - May 2017Technical expertise: 1. REACH, GHS and CLP Regulations.2. Knowledge on EU Cosmetic Regulation 1223/2009 (SCCS notes of guidance). 3. SAP EHS (Environment, Health, Safety), [Product Safety Stewardship]4. Knowledge on OECD guidelinesResponsibilities:1. Risk Assessment of Cosmetics/Personal care products and Chemicals.2. SDS authoring, Classification and Labelling of Chemicals as per GHS and CLP regulations.3. Non Clinical Overview (NCO -Toxicology data) for Pharmaceutical Actives.4. Formula evaluation of cosmetic products5. Preparation of Toxicological Profiles for cosmetic ingredients6. Preparation of Cosmetic Product Safety Report (CPSR) as per the EU regulation 1223/20097. Product safety assessment (margin of exposure, margin of safety)8. Hazard exposure and risk assessment for cosmetic/personal care products, nutrients, food products, household cleaning products.9. Conduct Literature search on toxicological data.10. Data base expertise: PCPC, TOXNET, INCHEM, IFRA, EPA, PUBCHEM, JECFA, ECHA, HERA, EFSA, OEHHA, PUBMED etc. Show less
Executive in Toxicology Department
Dec 2015 - May 2017Toxicologist
Jan 2015 - Jan 2016Toxicologist
Jan 2015 - Jan 2016

S H kelkar and Company Ltd
May 2017 - Apr 2021Executive regulatory affair toxicologist
S H Kelkar and Company Limited
May 2017 - Apr 2021Regulatory Affairs Executive1. Analysis of chemical substances, Fragrances and Flavor samples use in Personal care, Hair care, Skin care & Cosmetics, Fabric care, Household products and fine fragrances by using GCMS and GC analyzer.2. Check for compliance with EU cosmetic regulation, GHS, IFRA guideline, and various Customer specific policies3. Provide the detail information in Costumer specific Questionnaire with required regulatory documents.4. Working as a Executive in Regulatory affairs department from S.H. Kelkar and company limited for Fragrance and Flavour samples used in cosmetic and household products. Show less

Intertek India
Apr 2021 - Feb 2024Regulatory Toxicologist
Personal Care Regulatory
Feb 2024 - nowSenior ToxicologistCosmetics regulatory expert in CPSR, TRA, PIF, EU/UK Notification, and Artwork Review.
Licenses & Certifications

Good laboratory practices (GLP) certified
SA-FORD - Sanctuary for Research and DevelopmentJun 2013
QMS IRCA APPROVED ISO 9001:2015 LEAD AUDITOR
SGSMar 2018
Languages
- enEnglish
- maMarathi
- hiHindi
- saSanskrit
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