Preparing and submitting a regulatory dossier remains one of the most critical yet vulnerable processes in the pharmaceutical industry. The pressure to meet deadlines, ensure quality, and avoid rejections from regulatory agencies like AEMPS, EMA, or FDA can be overwhelming. Despite technological advancements, many teams still face obstacles that compromise the efficiency and accuracy of their dossiers.
In this article, we explore the five most common problems that jeopardize the quality and timelines of regulatory dossiers… and how Dossierfy, our new cutting-edge solution, can help you overcome them from day one.
1. Lack of Traceability and Document Control
When multiple teams work on different versions of the same file without a unified system, chaos is inevitable.
What happens?
- Critical changes get lost.
- It’s unclear who approved what.
- Information becomes inconsistent and unharmonized.
Consequences: Delays, costly errors, and, in the worst cases, regulatory rejections that damage the laboratory’s reputation.
With Dossierfy, you can:
Centralize everything in an intuitive platform that ensures you always work with the latest document version. Dossierfy provides a full change history, tracked validations, and controlled revisions, eliminating the risk of working with outdated or duplicated information.
2. Manual Processes and Lack of Coordination
Many dossiers are still compiled through exchanges of Word, Excel, shared folders, or endless email threads.
What happens?
- No visibility into pending tasks or clear responsibilities.
- Validations are done haphazardly or “from memory.”
- Milestone tracking is reactive, not proactive.
Consequences: Wasted time, duplicated efforts, and a higher risk of human error.
With Dossierfy, you can:
Automate repetitive tasks, generate smart checklists, and establish structured review workflows. Dossierfy ensures every team member knows exactly what to do and when, streamlining the process from planning to final submission.
3. Misalignment Between Departments
Regulatory Affairs, QA, Production, and Technical Affairs often work with different priorities and timelines, leading to friction.
What happens?
- Product or batch information is out of sync.
- Changes are poorly communicated or documented.
- Verification tasks are unnecessarily duplicated.
Consequences: Errors in the dossier that can delay regulatory approval.
With Dossierfy, you can:
Work in a centralized environment where all departments access the same validated information in real time. With automated alerts and full traceability, Dossierfy ensures seamless collaboration and reduces misunderstandings across teams.
4. Incomplete Review of Module 3
Module 3, due to its technical complexity, is particularly prone to errors.
What happens?
- Documents are approved without reviewing critical points.
- Justifications or cross-references are missing.
- Batch and method data are not properly aligned.
Consequences: Errors that can lead to regulatory queries, delaying product commercialization.
With Dossierfy, you can:
Leverage automated validation logic to identify inconsistencies before they become issues. Dossierfy enables document reviews based on predefined criteria, ensuring Module 3 meets all technical requirements from the start.
5. Rework and Agency Queries
A poorly prepared dossier can result in queries from agencies like AEMPS, EMA, or FDA.
What happens?
- Loss of credibility for the laboratory with regulators.
- Diversion of valuable resources to correct errors.
- Significant delays in product commercialization.
Consequences: Economic and reputational impacts that could have been avoided.
With Dossierfy, you can:
Minimize errors with proactive review tools and fully controlled documentation. Dossierfy helps you deliver complete, consistent dossiers ready for evaluation, drastically reducing the risk of regulatory queries.
Transform Your Regulatory Processes with Dossierfy
The quality of a regulatory dossier doesn’t depend solely on technical expertise—it also requires tools that optimize workflows, reduce errors, and enhance collaboration. Dossierfy is the solution designed specifically to tackle the challenges of pharmaceutical regulatory submissions, helping teams work more efficiently, accurately, and collaboratively.
Why choose Dossierfy?
- Centralization: All information in one place, accessible to all teams.
- Automation: Simplified repetitive tasks, from checklists to validations.
- Traceability: Full control over every change, review, and approval.
- Scalability: Tailored to the needs of laboratories of any size.
Ready to Defeat the Enemies of Your Regulatory Dossier?
Don’t let these challenges hinder your project’s success. Dossierfy is here to transform how you prepare and manage your dossiers, ensuring quality, compliance, and speed.
Interested in learning more? Contact us today to explore how Dossierfy can make a difference for your team.
