Your Partner for Global Regulatory, GMP Services & Third-Party Audits.
Your Partner for Global Regulatory, GMP Services & Third-party audits.
EU/ PICS/ TGAGMP gap assessment, Compliance advice and Bridging support, QMS documentation, Facility upgradation advice, Mock Audit, QP audit, EU GMP inspection-to-certification hand holding, Annual report submission for Pharmaceuticals, Biologics and Veterinary Products
For Biological facilities Metina additionally focuses on:
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, liasoning with regulatory authorities, inspection management and certification. Our internal team of ISO Certified lead auditors are fully equipped to handle preparation and certifications across categories (pharmaceuticals, biologicals) and dosage forms (orals, injectables, inhalers, Topicals and others).
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:
