Product Lifecycle Management

Metina provides end to end regulatory services starting from due diligence, gap analysis of the dossier, product development guidance, regulatory strategy, scientific writing of dossier, submission to health authority, query response and approval. Our services covers API and Formula...

Metina undertakes EU GMP project starting from pre-audit inspection, EU GMP slot arrangement and obtaining T&C letter from Authority, preparing plant for EU GMP inspection considering Hungary specific expectation of the authority, support throughout inspection, obtaining inspection observation repo...

Metina has efficiently managed multiple ANDA's submissions and approvals. Metina provides assistance starting from regulatory advice during product development, controlled correspondence with FDA, writing of scientific dossier in CTD, conversion into eCTD, online submission support to USFDA, query response...

Metina provide comprehensive support for the ARD and F&D Site GMP verification, API and FDF manufacturing Site GMP verification, BE and clinical site GCP verification and GLP verification audits. We extend the support to the storage facilities also.  

Metina has expertise in providing training on the regulatory guidance as both In-house and onsite training. The training topics are designed considering R&D, QA, QC, Production and Regulatory Affairs. Regulatory training can be diversified with more than 100 regulatory and quali...

Metina provides support to write USDMF for Pharmacopoeia and internal quality active substance, DMF, development advice, writing of CTD-DMF & eCTD submission to CDER, FDA, Deficiency response for complete assessment review of DMF, maintaining active status of DMF support in major change updates.  ...

Metina provides support to API manufactures one time audit by independent auditor for single API. It provides benefits to the manufactures to conserve company's resources (i.e. cost of travel and stay for buyer specific auditor, one-time engagement of manufacturing and QA personnel), one single QP audit ca...

Metina supports pharmaceutical company in developing required dosage forms at accredited formulation development laboratory, in line with EU / US reference product. Post development, the product technology would be transferred to suggested manufacturing location.  Metina can al...