PRAVIN KHARAT

PRAVIN KHARAT

Study personnel

Followers of PRAVIN KHARAT623 followers
location of PRAVIN KHARATNavi Mumbai, Maharashtra, India

Connect with PRAVIN KHARAT to Send Message

Connect

Connect with PRAVIN KHARAT to Send Message

Connect
  • Timeline

  • Skills

    Clinical trials
    Ich gcp
    Pharmacovigilance
    Pharmaceutics
    Regulatory affairs
    Glp
    Pharmacology
    Clinical development
    Sop
    Formulation
    Life sciences
    Pharmaceutical industry
    Toxicology
    Ind
    Research and development
    High performance liquid chromatography
    Good clinical practice
    Good laboratory practice
    Standard operating procedure
    Preclinical
    Drug testing
    Analysis
    Documentation
    Archiving
    Clinical pharmacology
    Laboratory animal
    Efficacy
    Adverse events
    Drug safety data sheet
    Msds
    Oecd
    Reach
  • About 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 - 2012
      Master's Degree Pharmacology and Toxicology A

      Master in Pharmacy in Pharmacology and Toxicology department

  • Experience

    • SA-FORD

      Sept 2012 - Jun 2013
      Study personnel

      Testing 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 2015
      Research 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 2016
      Toxicologist
    • Intertek

      Jan 2015 - May 2017

      Technical 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 2017
      • Toxicologist

        Jan 2015 - Jan 2016
      • Toxicologist

        Jan 2015 - Jan 2016
    • S H kelkar and Company Ltd

      May 2017 - Apr 2021
      Executive regulatory affair toxicologist
    • S H Kelkar and Company Limited

      May 2017 - Apr 2021
      Regulatory Affairs Executive

      1. 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 2024
      Regulatory Toxicologist
    • Personal Care Regulatory

      Feb 2024 - now
      Senior Toxicologist

      Cosmetics 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 Development
      Jun 2013
    • QMS IRCA APPROVED ISO 9001:2015 LEAD AUDITOR

      SGS
      Mar 2018