Consulting

  • Regulatory
  • Regulatory strategy development
  • Interface with regulatory agencies
  • Due diligence
  • Systems audits
  • Compliance
  • CMC
  • Technical evaluation of vendors, service providers
  • Evaluation and audits of manufacturing facilities
  • Interface with regulatory agencies
  • Regulatory submissions – INDs, IMPDs, QOS
  • Documentation – SOPs, reports
  • Nonclinical PK/TK/ADME and Clinical Pharmacology
  • Preclinical and Clinical PK Analysis using WinNonlin and Reporting
  • Prestudy Audits and Monitoring of preclinical studies for Regulatory Toxicology Studies conducted in India (OECD and FDA GLP)
  • GLP Toxicokinetics - TK analysis and Reporting
  • Training
  • Drug Discovery and Development process
  • Introduction to regulatory affairs
  • Clinical Trial regulations and process – India, US, EU, Canada
  • Overview of ICH and application to industry
  • Regulatory submissions – IND, NDA, ANDA, DMF, IMPD
  • Introduction to GMP , GLP and GCP and ongoing refresher programs
  • Toxicokinetics in GLP environment
  • Basics of Pharmacokinetics
  • Documentation
  • FDA - US INDs; pre-IND briefing packages, reports
  • EU CTAs; IMPDs, CTD
  • TPD - Canadian CTAs; QOS
  • Drugs Controller India – INDs, clinical trial application