Regulatory track record

Regulatory track record

Regulatory track record

  • 1991 - Italian MoH Approval
  • 2003 - First AIFA Inspection
  • 2008 - PMDA Japan
  • 2017 - FDA GMP Approval
  • 2019 - KFDA Korea
  • 2025 - AIFA — M2 Workshop
  • 2026 - AIFA Audit ✓ Passed

Approved & accredited by:  FDA  ·  AIFA  ·  PMDA (Japan)  ·  KFDA (Korea)  ·  ANVISA (Brazil)  ·  COFEPRIS (Mexico)  ·  Italian Ministry of Health

  • GMP Systems
    Purpose-built for HPAPI. Data integrity per ALCOA++. Controlled access, full audit trails, independent QA decision-making.
  • Cleaning Validation
    PDE/HBEL approach. LC-MS residue detection. Validated for equipment, isolators and auxiliary tools.
  • Stability Program
    ICH chambers (25°C/60%, 40°C/75%, 30°C/75%). Photostability ICH Q1B. EP, USP, BP, JP compliance
  • Quality Team
    16 QA/QC FTEs (+55% since 2019). Qualified Person on staff. Dedicated regulatory affairs function.

LET'S CONNECT

Our excellent team will be happy to conncect

CONTACT US