API Solutions

GMP

Asymchem APIs Intermediates GMP

Partner with a Proven GMP Facility

With a track record of fifteen regulatory audits from US FDA, TGA, NMPA (CFDA) and MFDS (SKR) as well as more than seventy customer audits a year, Asymchem has been committed to continuously and consistently assuring GMP compliance throughout our day-to-day operations across all sites. Our quality system is designed to be in compliance with the ICH Q7/Q8/Q9/Q10/Q11 guidelines and the international regulatory requirements and are considered fit for human consumption.

Approved GMP-compliant facilities offer peace of mind in addition to these benefits:

  • Ensured regulatory compliance from development, analytical services, and cGMP manufacturing to later stage development and commercialization with full CMC and RA support
  • Accelerated process development and scale-up under increased GMP requirements.
  • Enhanced regulatory audit readiness (pre-approval inspection or GMP re-inspection), including virtual audit capabilities
  • Track record of successful audits (FDA audit details here.)
  • Established registered starting material (RSM) assessment and regulatory concept.
  • Adherence to commercialization production timeline