Marketing Authorisation & New Market Access

  • Preparation and submission of Marketing Authorisation applications (MAA) in UK, EU, ANZ, MENA, APAC and USA regions.
  • Assist you through all the regulatory documents requirements and advice on filing strategy to ensure the correct legal basis and most appropriate submission route is used to ensure faster approval.
  • Marketing Authorisation transfers (change of ownerships) under in licensing and out licensing activities.
  • Due diligence of dossiers

Please contact Sushvin for more information.

Post Approval Licence Maintenance

  • All Minor/ Major variation applications i.e. CMC, Safety and admin preparation and submission
  • Product information update variation i.e. SmPC, PIL and Labelling
  • Site transfer/ addition submission
  • Renewal application preparation and submission.
  • Sunset clause exemption applications
  • Response to RFI preparation and submission.

Please contact Sushvin for more information.

Ad Hoc Activities

  • MIA set up and registration application
  • WDA set up and registration application
  • Controlled drug License application

Please contact Sushvin for more information.

CMC

  • Strategic consultancy during pharmaceutical development and lifecycle management.
  • CMC scientific and technical writing.
  • Compilation of quality dossiers (ICH and non-ICH)
  • CTD modules 3 and 2.3.
  • CMC maintenance support: change control and quality variations
  • GxP services (GMP, GACP, GDP) including audits.

Please contact Sushvin for more information.

Artwork & Labelling

  • Development and maintenance of EU regulatory product information
  • Preparation of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and label for marketing authorization applications
  • Communications with health authorities / agencies
  • Provision of labeling repository
  • Tracking and monitoring of status and key milestones
  • Artwork management
  • Translation services
  • Proof-reading and readability testing
  • Quality control

Please contact Sushvin for more information.

eCTD Publishing

  • Assist pharmaceutical organizations to streamline entire Regulatory submissions management process within Microsoft SharePoint regulatory database.
  • Dossier development, submission planning, tracking, publishing, and final submissions to Health Authorities (HAs) including delivery confirmation/acknowledgement.
  • As global HAs publishing in electronic format.
  • Publishing of region-specific formats for all kinds of submissions such as: paper, electronic, eCTD, and NeeS.

    • Please contact Sushvin for more information.

    Other Major Regulatory Services-

  • Engagement in Companies Merger and Acquisition regulatory activities.
  • Enter into emerging markets with existing and new products dossiers.

    • Please contact Sushvin for more information.

    Services We Offer.

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    Auditing Solutions

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    PMS - Post Market Surveillance/PMCF

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