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.  With offices in Australia and Singapore, we’re able to provide regional coverage in Australia, New Zealand, Singapore, Malaysia, Indonesia, Thailand, The Philippines, Vietnam, Taiwan, Hong Kong and South Korea.

We have experience over an extensive range of therapeutic areas including oncology, psychiatry, dermatology, infections and infectious diseases, immunology, pulmonary/respiratory disease, obstetrics/gynaecology, urology, gastroenterology and endocrinology.     

Regulatory Affairs

 

  • Asia Pacific Regulatory Affairs & Regulatory Strategy
  • Agency and pre-submission meeting representation
  • Dossier gap analysis
  • Marketing authorization applications/submissions
  • Non-commercial sponsorship
  • Post-approval variations and maintenance activities
  • Literature based submissions
  • Orphan drug designation applications
  • Special access scheme
  • Product launch activities
  • Antibacterial resistance data reports
  • Justifications for use of a foreign reference products and BCS bio-waivers for generic medicines
  • 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
  • Product/Sponsorship/MAH Transfers
  • Certificate of Pharmaceutical Product and export listing applications
  • Coordination of document legalisation and notarization
  • Import/Export permits
  • Translations of dossier

Market access and reimbursement

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

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

New Zealand

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

Asia (including 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

USA

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

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

Contact us for more information on regulatory and market access services.

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