GMP pre-audits, Compliance advise and bridging support, QMS documentation, Facility upgradation advise, mock up inspection, QP audit, EU GMP inspection to certification hand holding, annual report submission.
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.).
With its own subsidiary in Australia, Metina can provide end-to-end GMP & Regulatory Services for site and product approvals from the Regulatory agency of Australia : Therapeutic Goods Administration (TGA). Our team can work with clients to prepare their manufacturing facilities for TGA ‘on-site’ inspections or for Desktop Compliance Verifications. In case of on-site inspections, Metina will work on its established modus-operandi from gap-assessment, GMP preparation, mock audits, agency liasoning, inspection management & CAPA preparation.
As a registered client on on TGA eBS portal, Metina can provide the following services additionally to its clients :
Metina can provide support GMP preparation and agency liasoning for other Regulatory Agencies across the world based on the need of the client.