我们的优势

技术性协助

直接与法规单位进行联系与沟通协调
FDA, EU, WHO, EMEA, TFDA & MHRA

提供最新的国内外法规资讯
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