Pole Nord

eQSEpertise

Scientist1
Rocket1
  • Medical Devices
  • Pharmaceutical Industry
  • Combination Products
  • Chemical industry
  • Biotechnology
  • Agriculture / Agrochemistry
  • …..
  • GLP - Good Laboratory Practice

  • GMP - Good Manufacturing Practice (ICH Qx)

  • ISO 22716 (GMP cosmetics)

  • ISO 13485 - 21 CFR 820

  • CE Marking - directive 93/42/CEE : medical devices

  • ISO 31000 - ICH Q9 - ISO14971: Risk Management 

  • ISO/CEI 17025

  • Strategy / Management
  • Research and Development
  • Manufacturing
  • Services
  • .....
  • ISO 9001
  • ISO 14001
  • OHSAS 18001
  • Applicable standards for product requirements and test methods
  • .....
  • Whole Management System including all Stakeholders
  • Strategy, Marketing, Quality Processes
  • Drug/Device R&D, Design and Development, Design Control
  • Manufacturing, Supply chain, Procurement, Delivery
  • Means and Methods for Manufacturing and Control (Validation strategy)
  • Vendors / Suppliers (Agreement, Control, Audit & Assessment, Qualification)
  • ...

Standards and norms

Senior expertise covering

Businesses

ICA AFNOR  3rd Party Auditor trained