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AI-Powered, Human-Validated: The New Standard for Pharma Submissions

22 août 2025

DOCUMENT INTELLIGENCE

Pharmaceutical companies are under increasing pressure to speed up drug approvals while ensuring regulatory compliance.

Regulatory bodies like the FDA and EMA are actively exploring how AI can streamline and strengthen the submission process. In their most recent reports, both the FDA and EMA have acknowledged the growing role of AI in regulatory submissions, and its potential in drug development and approval^1,2.

Nevertheless, for many in the pharmaceutical industry, there remains some uncertainty around fully trusting AI-driven solutions, particularly when it comes to ensuring compliance and handling ever-evolving regulatory standards. A 2023 McKinsey report highlights that AI and machine learning (ML) have the potential to cut trial timelines by up to six months, improving net present value (NPV) and enabling quicker patient access to new therapies³. Moreover, up to 80% of clinical trials run behind schedule, highlighting the urgent need for automation and streamlined workflows to reduce delays and inefficiencies⁴. Generative AI has the potential to generate between $60 billion and $110 billion annually for the pharmaceutical and medical-product industries, according to McKinsey. This impact ranges from identifying new compounds to expediting approvals⁵.

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The Challenge of Global Submissions:

Managing regulatory submissions across different regions presents several challenges:

Varying regulatory standards: Different regulatory bodies, such as the FDA (U.S.), EMA (Europe), and other markets (e.g. China, Brazil) all have their own distinct submission formats and documentation requirements.
Fragmented data silos: Regulatory data is often stored in silos across various departments, making it difficult to ensure that the most current and complete information is being used7. In fact, nearly half of pharmaceutical companies report that data silos threaten their operational efficiency, creating barriers to timely and accurate regulatory submissions⁶. This fragmented structure hinders cross-functional collaboration and creates inefficiencies in the submission process, increasing the risk of errors and delays⁷.
Manual Processes: The submission process is often time-consuming and prone to human error, especially when data has to be extracted manually and formatted to meet different regional standards.

MedDossier Helps Streamline the Submission Process:

MedDossier, developed by Vivanti, addresses these challenges by offering a modular, lightweight solution that combines AI-driven automation with human oversight, ensuring that documents are compliant, accurate, and aligned with regulatory requirements across global markets. MedDossier plays a crucial role in streamlining data extraction and document compilation, helping pharmaceutical companies to reduce delays and accelerate submissions — all while remaining cost-effective and adaptable.

Here’s how MedDossier supports this process:

Data Extraction Relevant and Report Generation

MedDossier automates the extraction of relevant data from clinical trial reports, preclinical studies, and CMC (Chemistry, Manufacturing, and Control) documents. By automating this process, MedDossier ensures that only the necessary and accurate data is included in submission documents, reducing the chances of human error and ensuring the document is complete and accurate.
Ensures Version Control & Finalises Documents

MedDossier tracks all document versions, ensuring that only the most up-to-date version is used for the generation of the Submission Package.
Generates Submission Package for Review

After the data has been extracted, the document formatted, and compliance confirmed, MedDossier generates a complete submission package that is ready for review. The package is aligned with regulatory standards and is prepared for submission with minimal manual intervention but maximum human oversight.

Pharmaceutical leaders are already investing in internal tools to support AI-driven submission workflows. Merck, for example, developed GPTeal, a proprietary platform that enables over 50,000 employees to use AI for tasks such as regulatory document drafting and productivity optimisation⁸.

MedDossier: Human + AI Working Together for Compliance and Speed

The use of generative AI can accelerate regulatory submissions by up to 40%, improve cost efficiency by 50% across internal regulatory teams, and cut quality issues by half⁹.

Yet, a key concern for many pharmaceutical companies when adopting AI is — trust. Trust that the technology can handle critical tasks like data extraction and document generating without compromising or introducing inaccurate outputs.

MedDossier addresses these concerns by combining AI-driven automation with human oversight. While MedDossier automates the heavy lifting, human experts retain control over the final review and strategic decision-making, ensuring compliance and validating the final output. The importance of human oversight is echoed by the growing investment in AI literacy across the pharmaceutical sector. For example, Johnson & Johnson has trained over 56,000 employees in generative AI, while Eli Lilly requires AI certification for senior leaders and managers, ensuring cross-functional fluency in both biotech and digital domains¹⁰.

- Marina Hickson, Managing Director, Vivanti: "MedDossier was built with the understanding that while AI offers tremendous benefits in terms of speed and compliance, human oversight is critical to ensure that submissions meet the specific regulatory nuances of each market. We enable pharmaceutical teams to remain in control while benefiting from AI’s speed and accuracy."

MedDossier: A Modular and Lightweight Solution

MedDossier’s modular design makes it an ideal solution for pharmaceutical companies that may not have the budget or resources to implement end-to-end enterprise systems. Its lightweight architecture ensures that even smaller organizations can benefit from powerful AI-driven automation without the complexity or high costs typically associated with larger systems. Whether you’re handling regulatory submissions for a few products or a larger portfolio, MedDossier can be tailored to meet your specific needs, offering scalability and flexibility in a way that larger systems simply cannot.

Moreover, MedDossier is designed to seamlessly integrate with existing systems, making it a perfect complement to solutions like Veeva and others. This ability to work in synergy with other platforms ensures that companies can optimize their workflow without having to overhaul their entire infrastructure. The result is a streamlined process that balances the power of automation with the control and flexibility that pharma companies require.

Business Value for Pharma:

For pharmaceutical companies, MedDossier delivers significant business value:

Faster Submissions: By automating data extraction, reports generation, and document formatting, MedDossier accelerates the submission process, enabling faster approvals.
Cost Efficiency: Delays in regulatory submissions are costly, with a single day of delay potentially resulting in $500,000 in lost revenue¹¹. MedDossier helps reduce time spent on manual tasks, minimising costly delays and improving the speed to market.
Regulatory Compliance: MedDossier ensures that submissions meet the required regional standards, whether it’s for the FDA, EMA, or any other regulatory authority. It uses AI-driven templates, ensuring that documents are accurate, compliant, and ready for submission.

End-to-End Solution (Global: U.S. & EU Compliance):

MedDossier is part of a broader end-to-end solution offered by Vivanti. Report compilation, and document formatting for regulatory submissions across both U.S. and European markets.

Vivanti’s companion product, AURA, focuses on the data readiness phase, ensuring that structured content from different sources and sometimes different formats (such as product, safety, quality, and clinical data) is complete, validated, and compliant before MedDossier takes over. AURA helps regulatory teams stay aligned with evolving global data standards and supports submissions like eCTD 4.0, centralised procedures in the EU, and NDA/BLA filings in the U.S.

Used independently, AURA supports upstream data validation while MedDossier automates downstream submission workflows. Together, they provide a comprehensive, globally compliant end-to-end solution, streamlining the entire regulatory submission journey — from early data preparation to final approval.

Conclusion:

Regulatory submissions are one of the most resource-intensive parts of drug development and often the least efficient. MedDossier and AURA were built to change that. By combining automation with expert oversight, they help teams reduce manual work, avoid compliance risks, and move faster without cutting corners.

Rather than asking teams to trust AI blindly, Vivanti’s approach places control where it belongs: with experienced professionals. The technology handles the complexity in the background (extracting, validating, generating) while regulatory experts focus on strategy and final decisions.

For pharma companies under pressure to deliver results quickly and globally, this isn’t just a digital upgrade. It’s a practical, scalable way to improve how submissions get done.

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