- Quality and Scientific Regulatory Services for Global Bio-/Pharmaceutical Industry
GMP Excellence : EU/ PICS/ TGA/ Health Canada
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.
EU GMP Excellence
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 Liaoning, 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 Assessment Audit
- Gap Assessment Report Submission
- Management Meeting – Next Stage
- Regular visits to verify facility, utility, laboratory, personnel and quality system
- GMP Inspection application
- System upgradation advice
- Scheduling GMP Inspection
- Support throughout Inspection
- CAPA review and support till approval
- Securing EU GMP certification
- Updates on EudraGMP
- Annual report submission
- Renewals insepction support
PIC/S GMP Proficiency
NPRA, Malaysia is one the earliest agencies to secured PIC/S membership in January 2002, well ahead of most of the emerging markets.
Metina expedites product triggered GMP inspection through NPRA by application submission through Quest 3, support in screening deficiencies, fees payment and BE/CMC evaluation deficiencies response.
In addition, Metina offers Holding and Maintaining Marketing Authorisation with NPRA and Identifying importer / distributor post approval for product marketing.
The service encompasses scientific writing of dossier in ACTD format, drug product classification and support till approval.
PIC/S GMP inspection service would cover submission of request letter, inspection dates finalization with inspection committee, preparing manufacturing site as per PIC/S GMP guide, CAPA submission till site licensing.
The NPRA issued PIC/S GMP license is well acknowledged by Ukraine, Thailand, Singapore, Taiwan, Hong Kong, Turkey, Argentina, Mexico etc.
Metina also support BE/Clinical Center GCP inspection and approval through NPRA.
TGA GMP
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 :
Act as the Australian sponsor to provide all the sponsor support services required for the TGA application, for companioes who do not have presence in Australia.
Provide end-to-end assistance in Desktop Clearing Applications (CV and MRA based).
Act as an agent for companies for TGA Applications by providing a liaison channel and mechanism of communication between the sponsor and the TGA.
Support all activity towards maintaining the lifecycle of Generics and Prescription medicines, and all types of Variation Application (i.e. Brand name change, shelf-life, sponsorship transfer etc.)
Health Canada, WHO GMP, Others
Metina can provide support GMP preparation and agency liasoning for other Regulatory Agencies across the world based on the need of the client.