Metina PharmConsulting Private Limited
About Metina PharmConsulting Private Limited
Categories
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IN -
2015On CPHI since
Company types
Contact info
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901-903, Goodwill Infinity, Sector 12, Kharghar, Navi Mumbai, India
Products from Metina PharmConsulting Private Limited (9)
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Product API EU QP Audit
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... -
Product Drug Product Development, CDMA identification and Technology transfer of product
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... -
Product Regulatory Services for small molecules
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... -
Product EU GMP
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... -
Product ANDA Submissions and Approvals
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... -
Product GxP Inspection Service
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. -
Product Regulatory Training
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... -
Product USDMF, ASMF (EU-MSs), CEP (EDQM)
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. ... -
Product Product Lifecycle Management
Commitment to conditional approval, PV Compliance, Annual Report, CBE and PAS to USFDA, Type I &II variation for EU, Maintenance of Registration, Renewal & Re-registration and Line Extension.
Metina PharmConsulting Private Limited Resources (1)
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