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AMCP Dossier and Global Dossier Services

It is becoming increasingly more important, particularly in the US, to provide clinical and economic evidence of biopharmaceutical products for formulary decision-makers in the AMCP dossier format.

Be Prepared with a Robust AMCP Dossier or Global Dossier for Your Product

Often required or requested by Health Plans for consideration in the formulary decision-making process, the AMCP Dossier is a critical tool to demonstrate the value of your product for maximum success in the market place. As important as your label, and able to convey a greater body of clinical and economic evidence, pro-actively approaching this step in the development process to create a high quality AMCP dossier will position you for success. It may also help to increase or expedite the review process by providing information in a standardized format for reviewers.

AMCP Dossier and Global Dossier Consulting Services:

  • Complete Dossier Content Development
    • Product Information
    • Clinical and Economic Information
    • Retrospective Claims Analysis
    • Cost effectiveness Modeling (cost per QALY, cost utility, cost minimization or cost benefit model)
    • Budget Impact Model
    • Modeling Report
    • Overall Clinical and Economic Value Proposition
    • Setting of Care Considerations and Associated Payment Values
  • Existing Dossier Assessment and Improvements

Value Proposition

  • Benefit of pro-actively having AMCP or Global dossier complete and reviewed versus having to provide it re-actively
  • Clearer understanding of product information by reviewers
  • Potentially faster review times and therefore earlier product uptake
  • Potentially better formulary placement for increased product uptake

Contact Us

For further information and to get in touch with our experts, please use our contact us form and type "AMCP or Global Dossier" in the comment field so we can assign the right expertise for further discussion. Thank you!

About PAREXEL Consulting

We offer biopharmaceutical and device consulting services  supporting strategic partnering, product globalization, development optimization, reimbursement & market access, strategic compliance, biologics development and commercialization, follow-on biologics development and commercialization, and medical device development and commercialization.