About Us › Quality Assurance

Quality Management System

By structured framework we ensure that our work consistently meet your expectations. 

  • Quality document hierarchy

Quality Manual

Applicable standards include (not exclusive)

  • ICH E3 · E6 · E9

  • ICH Q9 · Q10

  • EudraLex Vol 4 (Annex 11 and 15) and Vol 10

  • GDPR

  • FDA Guidance for Industry, as relevant

  • PIC/S Guidence

  • GAMPP5

Standard Operating Procedures

Forms (WIs · Checklists · Templates)

  • Regular 3-years review cycle

  • Availability of controled documents via CLIN-LINK