我們的優勢

技術性協助

直接與法規單位進行聯繫與溝通協調
FDA, EU, WHO, EMEA, TFDA & MHRA

提供最新的國內外法規資訊
such as.. ICH, ISO, PDA, ISPE, ASTM, ANSI

IN-HOUSE QUALITY ASSURANCE SERVICES

Our consultants have been engaged to provide rotational onsite Quality Assurance Systems support, in the absence of permanent quality personnel. We can provide options for temporary staffing.

  • QA – Documentation Control
  • QA – IPQC/IPQA (In-process)
  • QA – Reviewer (SOP/BMR/BPR/Records/Reports)
  • QA – Auditor (Internal / External)
  • QA/VA – Validation or Qualification