Dossier Due Diligence
- Clinical due diligence / gap-analysis
- CMC due diligence / gap-analysis
- Remediation of old dossiers
- Consulting on registration pathway for old dossiers
- Evaluation the regulatory feasibility of achieving product approval in the target markets
- Evaluation of BE Studies
- 50+ Dossier due diligence performed
- 10+ Clinical study audits performed
- 30+ Dossiers remediated
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When is it advisable to perform a Dossier Due Diligence?
Dossier due diligence is especially important for old dossiers and those acquired through mergers, acquisitions, or in-licensing. These dossiers may not meet current regulatory standards or might contain gaps that could hinder product approval. Performing due diligence ensures that these dossiers are thoroughly evaluated, updated, and aligned with current requirements, reducing risks and streamlining the path to market. This process is critical to avoid delays and complications during regulatory submissions or market entry.
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What are the timelines to perform a Dossier Due Diligence?
The timelines for performing dossier due diligence can vary depending on the complexity and condition of the dossier, number of strengths, Drug substance manufactures, CEP/ASMF and other. However, the process typically takes several weeks to a few months. This timeframe allows for a thorough review, gap analysis, and necessary remediation to ensure compliance with current regulatory standards. Specific timelines can be better estimated after an initial assessment of the dossier's condition and the scope of the review required.
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What is the deadline for EAEU MAA upgrade (bringing dossiers into compliance) procedure?
Effective January 1, 2026, all registration certificates for medicinal products registered under national legislation will be annulled if they do not comply with the Eurasian Economic Union (EAEU) requirements. Currently, a transitional period is in effect in EAEU countries, concluding on December 31, 2025. During this period, medicinal products registered under the legislation of EAEU member states must be brought into alignment with the Union's requirements and regulations.
Perpetual registration certificates issued under national procedures will also remain valid only until December 31, 2025. By this date, the registration dossiers for medicinal products, which were prepared according to member states' legislation, must be updated to comply with the Union's requirements.