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Regulatory Affairs services

 A 360ยบ Services including but not limited to:

  • STRATEGIC PLANNING FOR MA SUBMISSION

    • Comprehensive Analysis of the Product and its Market Environment;
    • Market Access for Commercial Advice;
    • Analysis of all applicable Regulatory Requirements in any of the desired territories;
    • Intellectual Property and Intelligence Gathering.

     

  • GAP-ANALYSIS OF ALL DOCUMENTATION

    • Comprehensive analysis of the documentation considering the different requirements from different regions around the planet.
    • Preparation of an Extended Report underlining major and minor findings and suggesting all applicable adaptations what will be necessary for Dossier Compliance.
  • ELABORATION OF MA DOSSIER SPECIFIC DOCUMENTS

    • Preparation of all Documentation required for Dossier Submission including.
    • LeDrew Healthcare can also act as MAH and PV Provider for specific procedures.
  • SUBMISSION OF MA DOSSIER UNTIL APPROVAL

    • Dossier Submission through different formats in the EU and other emerging countries;
    • Liaison with the Authorities for slot booking and management of the evaluation phase;
    • Answering to LoDs that may arise from the Authorities;
    • National phase management, including all applicable translations and mock up preparations.
    • LeDrew Healthcare ensures a comprehensive and critical analysis of each procedure, assuring its success and reduction of LoDs that may arise.
  • PRODUCT LAUNCH

    • Price and Reimbursement Requests;
    • Mock-up Review before Market Entrance;
    • Obtain License for Distribution of the Product;
    • Partner Search for Product Distribution;
    • Promotional Material Review and Elaboration;
    • 3rd Market entrance after approval of MA in the target country.

     

     

  • MA MAINTENANCE ACTIVITIES

    While predicting long-term variations according to the regulatory intelligence and Assuring the Dossier Consolidation LeDrew Healthcare performs:
    • Renewals;
    • Line Extensions;
    • MAH transfers;
    • MA Withdrawn and Submission of Copies and Duplicates for 3rd parties.