ANDA Submissions and Approvals

ANDA Submissions and Approvals
Product Description

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 and product approval.

Metina PharmConsulting Private Limited

  • IN
  • 2015
    On CPHI since
Company types
Consultancy
Contract Service

Metina PharmConsulting Private Limited

  • IN
  • 2015
    On CPHI since
Company types
Consultancy
Contract Service

More Products from Metina PharmConsulting Private Limited (8)

  • API EU QP Audit

    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...
  • Drug Product Development, CDMA identification and Technology transfer of product

    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...
  • Regulatory Services for small molecules

    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...
  • EU GMP

    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...
  • GxP Inspection Service

    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.  
  • Regulatory Training

    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...
  • USDMF, ASMF (EU-MSs), CEP (EDQM)

    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 Lifecycle Management

    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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    Do you have lots of products and/or products' data which you cannot organize/archive interna...
  • Product Custom Protein Synthesis

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  • Product Value-added generic development

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    Although in general the overall aim of value-added generic development projects is focu...
  • Product ANDA and NDA Technical Support

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  • Product Auditing

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  • Product Pharmcovigilance

    Pharmacovigilance services:
    › Automated literature search and assessment
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    › Pharmacovigilance system
    › EU-QPPV, graduated plan officer, information officer

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    AUDITING: - Support its clients on Vendor Audit; COMMISSIONING:- Manages and performs commissioning activities for new systems, equipments and facilities; 
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    COMP...
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    If the thermal mapping of warehouses and storage areas of the materials along the entire production and distribuition chain is complicated because of the heterogeneity of the environments and of the conditions (just think about the transporters), the qualification of production locals or of laboratori...
  • Product Pharmintech Exhibition

    PHARMINTECH is one of the most important international exhibitions dedicated to processing, packaging and digital solutions for the Life Science industry.  PHARMINTECH welcomes you in Bologna from 10th to 12th April 2019.
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  • Product Precious Metal Recovery from Pharma Reactions

    Catalyst characterisation based on an extensive knowledge base and experience, will determine a tailored treatment process, which will deliver the best value returns. Understanding your process where the catalyst is utilised will help determine the treatment route and matrix effects, such as the residual ...
  • Product CONSULTING SERVICES

    SciencePharma is a leading, highly experienced consultancy company providing state-of-the-art services in a field of nonclinical and clinical studies. We gather a qualified team of experts, who carry‑out tasks from the various stages of projects/studies. As the consultancy company we deal with diversity is...
  • Product HVAC , DUCTING AND BMS

    IN HOUSE TECHNICAL STRENGTH CONCEPTUAL-BASIC-DETAIL DESIGN ERECTION-COMMISSIONING-VALIDATION COMPLIANCE-BMS 21 CFR PART 11
    AHU –DH UPTO 35% EFFECTIVE LATENT COOLING HIGH ENERGY PERFORMANCE LOW CAPITAL INVESTMENT
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  • Product RESEARCH AND DEVELOPMENT

    We offer research and development services at all stages of the production of capsules, from idea to finished product for medicinal products, medical devices, food supplements, cosmetics and veterinary products.

    We offer our clients a proper identification of their needs and requirements, r...
  • Product Regulatory Affairs

    We provide solutions to meet both local and global regulatory requirements in the most cost-effective manner.

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  • Product IT/EU REGULATORY AFFAIRS - Support and management of RA practices

    OP Pharma has been providing all-around services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.
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  • Product Compliance Management

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  • Product Thermal Mapping

    We protect the integrity and quality of your temperature sensitive pharmaceutical products to meet all regulatory requirements

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  • Product QUALIPHARMA

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  • Product Facility Design & Project Management

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