Navigating today’s regulatory landscape is more challenging than ever. The rapid proliferation of global regulations contributes to information overload, while the lack of centralized, consistent resources makes it difficult for teams to stay aligned. Monitoring relevant changes, identifying regulatory roadmaps of upcoming changes and assessing their impact on current products or practices demand significant time and effort. By combining deep regulatory expertise and globally curated content with powerful, trusted AI capabilities, organizations can develop more effective, compliant regulatory strategies.
Boosting productivity with AI in regulatory compliance
Regulatory teams operate in a fast-moving global environment where the volume and complexity of information can quickly overwhelm. An AI-driven regulatory system, such as the Regulatory Assistant, which was recently launched on Cortellis Regulatory Intelligence, helps teams work more efficiently by making critical information easier to access, interpret and act on. Conversational search and interactive document analysis allow users to ask questions in natural language and receive clear answers linked to the original sources, cutting down the time spent digging through documents.
AI-driven features in Regulatory Assistant, a purpose-built solution delivering AI in pharma compliance, include automated document summaries, highlighted differences between versions and multi-language support. By delivering insights alongside the raw information, Regulatory Assistant helps regulatory professionals stay aligned on compliance obligations, proactively respond to change and focus on risk management and market expansion rather than data gathering.
Grounding AI in high-quality, accurate data
Because accuracy underpins every regulatory decision, a regulatory intelligence system supported by AI should be built on high-quality, trusted content. Regulatory AI built on curated intelligence and agency documents stands apart from both general-purpose chatbots and regulatory tools that lack trusted sources.
A system designed with the user context in mind delivers tailored responses that align with the expectations of regulatory professionals. Answers are always linked to licensed, accessible content, with clear indications when information falls outside a user’s subscription. This transparency prevents assumptions from being mistaken as fact.
Behind Regulatory Assistant sits an extensive repository of global regulatory intelligence, covering more than 80 countries and regions as well as drugs, biologics, medical devices and diagnostics. Curated insights from subject matter experts and rigorous quality controls enhance reliability. With comprehensive coverage, careful curation and validation, AI solutions like Regulatory Assistant deliver outputs that are accurate, relevant and actionable for regulatory teams.
Grounding AI in regulatory expertise
The strength of any regulatory AI system depends on the depth of expertise behind it. Regulatory Assistant is backed by 30+ years of experience with regulatory intelligence, spanning product approvals, inspections and evolving market pathways, meaning it can truly support informed strategy and compliance.
Localized subject matter experts with domain expertise in regulatory affairs and scientific disciplines play a critical role in shaping these systems. Their knowledge ensures that outputs reflect how regulators actually interpret requirements, enabling accurate comparisons and guiding effective market entry strategies.
When AI is combined with domain expertise, the result is not just faster answers but more reliable insights. This blend of technology and human knowledge enables organizations to maintain compliance, expand to new markets and tackle even the most complex regulatory challenges.
Building trust with a robust data foundation
In the realm of regulatory compliance, the efficacy and adoption of AI tools hinge on the establishment of trust, by producing accurate outputs and ensuring maintenance of both data privacy and data integrity. Accuracy is achieved by grounding responses in curated, trusted regulatory sources, along with human review and oversight of the outputs. For example, Regulatory Assistant links each answer to references from the source text, giving users visibility into where the information originated and the opportunity to verify the accuracy of the information. When sufficient data is unavailable, the system explains the gap rather than fabricating an answer.
In addition, purpose-built models further ensure outputs are tied only to vetted organizational content, with full transparency and source attribution. Privacy strengthens this trust by keeping query data anonymized, securely stored and inaccessible to external parties, including public models.
Ongoing validation and oversight by subject matter experts, which is an important component of any system providing AI-generated information, contribute to reliable outputs. Testing against regulatory sources, structured evaluations and beta programs for real-world feedback help ensure that responses remain consistent, accurate and aligned with compliance expectations. These safeguards enable AI systems such as Regulatory Assistant to become trusted components of compliance workflows.
Regulatory Assistant integrates AI models with Clarivate’s industry leading solutions, including Web of Science, trusted by hundreds of pharmaceutical and life sciences organizations worldwide.
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