Regulatory Affair

• QMS Implementation (ISO 13485/SS620/GDPMD/ GLP/ISO 9001/ISO 17025/ISO 15189/PIC’S/WHO-GMP
  and GDP).
• Product registration and licence holding in ASEAN countries for Medical Devices/ IVD/ Pharma/ Cosmetics
•  Technical file writing and product registration for CE
  Mark and US FDA
• Regulatory and QA consulting / Strategy development
• Design and Development, R&D compliance document, and Clinical evaluation document preparation for Research projects
• Outsourcing – QA and Regulatory affairs works.