EU GMP Excellence

EU GMP ( Pharmaceuticals/ Biologicals)

Metina undertakes end-to-end services for EU GMP certification for manufacturing sites across the world. Our services cover gap –assessment, end-to-end preparation, agency liasoning, inspection management and certification. Our internal team of ISO trained Lead Auditors are fully equipped to handle preparation and certifications across categories (pharmaceuticals, biologicals) and dosage forms (orals, injectables, inhalers, etc.).

  • Gap analysis audit & report
  • Regular visits to verify facility, utility, laboratory, personnel and quality system
  • System upgradation advice
  • GMP Inspection application
  • Scheduling GMP inspection
  • Support throughout Inspection
  • CAPA and support till approval
  • Securing EU GMP certification
  • Updates on EudraGMP
  • Annual report submission
  • Renewals insepction support


Metina has established a strong credibility in the industry in the domain of EU GMP. With over 30 certifications of manufacturing sites across countries, we have a high degree of success till date. Metina remains your best choice for partnering on EU GMP due to the following reasons:

  • Highly experienced team in the domain of EU GMP
  • Experience across varied Dosage Forms and categories
  • In-house expertise on small molecules and biologicals
  • Strong understanding of EU regulations
  • Well prepared for Distant Assessments with a detailed operational plan in place
  • Over 30 Distant Assessments carried out during imposition of COVID related travel restrictions

To read more about Metina’s services on Biologicals and Vaccines, click here.

EU GMP Excellence - Case Study

Read varied GMP challenges we overcome