Comprehensive GMP Audits and Quality Compliance Services

We support pharmaceutical, biotech, and medical device companies in achieving and maintaining compliance with global quality standards.

Our Services Include:

• EU GMP Inspection Support
  • End-to-end support for EU GMP (Good Manufacturing Practice) inspections, including facility due diligence by our expert team under the guidance of a Qualified Person (QP), readiness assessments, and final GMP audit conducted by a European QP.
  • Assistance in initiating and facilitating EU GMP inspection requests with competent authorities
  • Coordination and management of EU agency audit schedules
• Support in addressing and closing post-audit compliance findings to ensure successful certification.
• Site registration application support  and/or GMP Inspection support for GCC and other emerging country submission
• Mock inspections, and CAPA implementation