Regulatory Affairs

Pharmacovigilance

  • Serious/Non serious ICSR
  • DSUR
  • PSUR etc
  • Toxicological risk assessment
  • Exposure limit assessment (PDE/ADE/OEL)
  • Material safety data sheet (SDS/MSDS) services
  • Drug Master File (DMF)
  • ECTD/CTD (Common technical document)

Drug discovery and development:

  • Preclinical efficacy and toxicity evaluation support for nutraceuticals
  • Toxicity evaluation of agrochemicals
  • PCT studies for biosimilar
  • ADME studies and PK studies
  • Bio analysis and analytical services i.e. LC-MSMS and HPLC analysis
  • Cell and molecular bioassays
  • Microbiology studies
  • Acute, long-term toxicity studies and Genotoxicity studies

Scientific and medical writing

  • Health economics
  • Systematic Literature Review
  • Focused Literature Review
  • Meta-analysis
  • Network meta-analysis (ITC)
  • Publication support
  • Clinical trials
  • Bio equivalence studies