Quality

Unique experience gleaned from decades of experience in drug and medical devices.

Quality Management

APOMed leverage our unique experience gleaned from decades of experience in having hands on experience in the pharmaceutical and medical device industries. We can assist your organization with the following:

  • CAPA'S

  • Quality System Regulations

  • ISO 13485

  • QMS Audits

  • European CE Marking

  • Technical Files

  • Japan PAL

  • China SFDA

  • Sterilization

  • Internal and Supplier Audits

  • FDA Mock Audits

  • 483 & Warning Letter Responses

  • ISO 14971

  • Validations

  • Design Control

  • Risk Analysis & Management

  • DHF Development

  • GMP