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 is a broad-spectrum regulatory services provider, offering a diverse range of pre- and post-marketing regulatory and market access services to pharmaceutical, biotech, medical device and other life sciences companies.