Quality Compliance for Medical and Pharmaceutical Products

Ensuring Regulatory Alignment and Product Integrity Across Markets

Maintaining stringent quality standards is vital to successful product registration, manufacturing, and distribution in Asia’s diverse regulatory landscape. At Scansio, we help pharmaceutical and medical device companies establish and maintain robust Quality Assurance (QA), Quality Control (QC), and Quality Management Systems (QMS) that align with international and country-specific regulations.

Our Quality Compliance Services Include:

• On-Site Audits and Inspections:
  Our qualified auditors across Asia, including China, India, Vietnam, and Japan, perform detailed factory audits, process evaluations, and compliance inspections using international best practices such as ISO 13485, ISO 9001, CFR 820, and GMP standards.
• Third-Party Laboratory Testing Coordination:
  We identify and engage certified laboratories to perform independent quality testing, helping ensure your products meet global safety and efficacy benchmarks.
• Staff Training and Capacity Building:
  We train local personnel on global quality and compliance protocols to build in-house expertise and reduce long-term risks.
• Document Preparation and CAPA Planning:
  Our team prepares all necessary quality documentation and supports Corrective and Preventive Action (CAPA) planning for identified gaps.
• Due Diligence and Compliance Audits:
  We conduct comprehensive quality audits for new partners, CMOs, and suppliers to ensure transparency and trust in your supply chain.

With Scansio as your partner, you gain local insight combined with global quality standards—ensuring seamless compliance, reduced risk, and consistent product excellence throughout Asia.