Regulatory Affairs and Clinical Trials:

  • New Product Authorizations - Finished Products
  • New Market Authorizations - APIs
  • Post Approval - CMC and Life Cycle Management
  • Regulatory Assessment | Gap Analysis
  • Regulatory Consulting and Strategy
  • Health Authority Queries – Responses | Interactions
  • Regulatory Labelling
  • Clinical studies for innovative and/ or generic molecules
  • Clinical pharmacy and clinical Trials
  • Nuclear pharmacy
  • Pharmacy community
  • QC & QA: quality control and quality assurance
  • Medical and clinical case reports
  • Pharmacovigilance
  • Drug interaction studies
  • Polypharmacy
  • Investigational New Drug (IND) Application with FDA
  • New Drug Application (NDA)
  • Validation and Regulation
  • Pharmacovigilance and Risk Management