US:

U.S Authorized Agent / In-Country Care Taker

Drugs:

• Product Life Cycle Management
• Clinical Studies
• Regulatory Strategy Consulting and Liaison
• Drug Master File(U.S DMF)
• IND, NDA, BLA, ANDA, OTC
• Dossier compilation & conversion of CTD to e-CTD
• Labeling
• Annual Report
• Query Management
• 21 CFR Part 11 Consulting
• Risk Management
• Pharmacovigilance
  • PSUR
  • PV Consulting (AERS, SAERS, Case Reporting, Literature Search, etc.)
  • Medical Communication, Training, and 24/7 Call Center

Devices:

• Product Life Cycle Management
• Regulatory Strategy Consulting and Liaison
• Establishment registration and Drug / Device Listing
• 513(g) – Obtaining Device Classification
• Device Master File, 510( k), PMA, IDE
• Predicate Devices & Literature Search
• Quality Management Systems
• GxP Audits and Compliance Consulting
• Labeling
• Clinical Studies
• Commercialization
• Post marketing Vigilance studies and Risk Management
• Medical Communication, Training, and 24/7 Call Center