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Regulatory Strategy And Dossier GAP Analysis

Regulatory Strategy

We set you up for regulatory success by managing the entire process from dossier writing to filing applications. Biomapas’ experienced regulatory affairs specialists hold an unmatched reputation for exceeding expectations, and their knowledge of the regulatory authorities covers all of the EU and EAEU/CIS region.

To achieve your regulatory and business goals, we tailor comprehensive regulatory affairs strategies for your product, ensure milestones are met, and pave the way for successful submission.

Dossier GAP Analysis

Dossier GAP analysis involves a critical and scientific analysis of your medicinal product documentation. Properly analyzed and assessed medicinal product dossiers conform to local requirements lead to easier registration procedures.

We provide the following services in the medicinal product dossier evaluation according to Health Authority regulations:

  • Verification of missing points on full dossier or by separate Modules:
    • Administrative data (Module 1)
    • Non-Clinical and Clinical Summaries, Overviews (Modules 2.4-2.7)
    • Non-Clinical and Clinical Safety and Efficacy Data (Modules 4 and 5)
    • Provision of GAP analyses report with recommendations on the dossier amendment.

The dossier will be examined by our internal and external experts to highlight probable weak parts and possible gaps in information extensiveness and relevant and suitable solutions to update the missing on improper information.