Regulatory and Market Access Services

Regulatory Affairs

  • Asia Pacific Regulatory Affairs & Regulatory Strategy
  • Agency and pre-submission meeting representation
  • Non-commercial sponsorship
  • Literature based submissions
  • Marketing authorization applications/submissions
  • Post-approval variations and maintenance activities
  • Orphan drug designation applications
  • Antibacterial resistance data reports
  • Dossier gap analysis
  • Special access scheme
  • Justifications for use of a foreign reference products and BCS bio-waivers for generic medicines
  • Product launch activities
  • Clinical Trial Applications (Asia only)
  • Renewals (Asia only)

Regulatory Operations

  • Submissions Publishing – eCTD, NeeS and paper
  • Submission hosting and life-cycle management
  • Prescribing Information management
  • Artwork and labelling services
  • Certificate of Pharmaceutical Product and export listing applications
  • Coordination of document legalisation and notarization
  • Product/Sponsorship/MAH Transfers
  • Import/Export permits
  • Translations of dossier

Market access and reimbursement

  • Health Technology Assessment
  • Treatment Algorithm Development
  • PBAC Submissions
  • Commercialisation
  • Strategic Assessment
  • Clinical Surveys
  • Economic Modelling
  • QALY calculations
  • Market Analysis & Forecasting
  • Data procurement and analysis
  • Monte-Carlo Simulations
  • Meta-Analysis

Country Specific

Australia

  • Preparation and submission of Category 1 Applications
  • Response to Requests for Information (Section 31 Requests)
  • Category 3 Applications and Notifications
  • Export Listing Applications
  • Certificates of Pharmaceutical Products
  • ARTG Applications
  • Non-commercial sponsorship
  • Liaison with TGA
  • Pre-submission meetings

Asia (& ASEAN)

  • Regulatory Requirements and Dossier Preparation
  • Preparation of application forms in local language
  • Registration and licence applications
  • Dossier conversion & submissions (ICH CTD and ACTD formats)
  • Liaison with National Regulatory Authorities
  • Non-commercial Local Marketing Authorization Holder (MAH)
  • Compliance and Maintenance of Marketed Products
  • Thai eCTD publishing

New Zealand

  • Preparation of New Medicine Applications and Changed Medicine Notifications
  • Non-commercial sponsorship
  • Liaison with Medsafe

Canada

  • Preparation and submission of Abbreviated and New Drug Submissions (ANDSs and NDSs)
  • Responses to Clarifaxes
  • Notices of Non-Compliance
  • Level 1, 2 and 3 Variations
  • Annual Reports

Europe

  • Preparation and submission of Marketing Authorisation Applications (MAAs) (via centralised, decentralised or national procedures)
  • Responses to Questions
  • Type 1A, 1B and II variation applications
  • Renewals

USA

  • Preparation and submission of Abbreviated and New Drug Applications (ANDAs and NDAs)
  • Amendments
  • Supplements (CBE-30, CBE-0, Labelling Supplements)
  • Annual Reports

Market Access Services

Pharma To Market partners with KMC Healthcare to offer market access services. 

KMC Healthcare specialises in the provision and reimbursement of pharmaceuticals in Australia, New Zealand, Asia and Europe. Since 2000, they have been advising the pharmaceutical sector from the largest multi-national manufacturers and suppliers to wholesalers and community pharmacy as well as their representative organisations.