Pharma Consultancy

REGULATORY SERVICES


  • Regulatory Compliance
  • Medical Devices
  • Registration Dossiers Audits
  • Regulatory Counseling during Clinical Development.


QUALITY MANAGEMENT SYSTEMS


  • GDPs Implementation
  • GMP Support
  • Quality Systems Implementation
  • GMP Compliance Adviser


Our Consulting Services Includes:

Outsourced Regulatory Affairs

Project-Based Regulatory Strategy and Submissions

  • Regulatory Strategy Consulting
  • FDA Meetings (including the Pre-IND Meeting, End of Phase 2 Meeting, Pre-NDA Meeting, FDA Advisory Committee Meeting)
  • FDA Submissions (including IND Submission, NDA Submission: 505(b)(1) and 505(b)(2) Assistance, Orphan Designation, ANDA Submission)
  • Regulatory Due Diligence

Quality & Compliance

  • Good Clinical Practice (GCP) Audits
  • Good Manufacturing Practice (GMP) Audits
  • Quality Systems & Quality Management