Pharmaceutical Regulatory and Compliance Solutions
Track regulatory changes, accelerate approvals, and support pharma regulatory compliance across global markets
Comprehensive regulatory compliance solutions for the entire drug lifecycle
Empower your teams with comprehensive pharmaceutical regulatory compliance tools that streamline workflows, reduce risk, and accelerate time to market. From drug discovery through post-approval, our AI-powered compliance tools deliver the intelligence you need to navigate complex regulatory landscapes with confidence.
Master global regulatory requirements
Streamline CMC dossier preparation
Anticipate regulatory safety concerns
Transform your pharmaceutical regulatory compliance approach
From de-risking development to submission planning, reduce compliance burden and accelerate regulatory success
Minimize regulatory risk
Never miss critical regulatory changes with Cortellis Regulatory Intelligence‘s daily alerts covering FDA, EMA, PMDA, and 80+ agencies. Stay informed of new guidelines, submission requirement updates, and enforcement actions before they impact your pipeline, helping you identify and address potential compliance issues before they cause delays and rejections.
Accelerate time to approval
Cortellis CMC Intelligence consolidates scattered requirements from 137 countries into one organized source in CTD Module 3 format. Compare regulations side-by-side, access expert insights on local practices, and plan submissions with confidence, reducing the months typically spent searching multiple sources.
Expand to new markets with confidence
Enter new markets strategically by understanding both regulatory submission requirements and CMC expectations before you commit resources. Access country-specific intelligence in English with expert guidance on local practices, enabling informed go/no-go decisions and successful first submissions in markets where you lack experience.
Make informed strategic decisions
Evaluate regulatory feasibility across your pipeline by analyzing approval trends, CMC complexity by market, and class-based safety landscapes. Identify which development candidates face the clearest regulatory paths, where to prioritize resources, and which markets offer the best risk-reward profiles, optimizing your portfolio strategy with comprehensive intelligence.
Strengthen regulatory submissions
Combine regulatory precedent analysis, compliant CMC sections, and proactive safety risk assessments to create stronger dossiers. Understand what regulators expect based on recent approvals, ensure your CMC meets country-specific requirements, and address safety questions before they’re asked, increasing first-cycle approval rates.
Resources
How pharmas and medtechs can navigate regulatory disruption in Washington, D.C.
A new administration in Washington has brought with it sweeping change across key health regulatory agencies—and life sciences companies are feeling the impact. From FDA resource shifts to emerging trade tensions and Congress-led policy proposals, the current landscape poses real and immediate risks to drug and device development, supply chain stability, and regulatory timelines. In...
5 key time-saving benefits of AI-driven regulatory intelligence
Pharma and MedTech regulatory teams are under increasing pressure to keep pace with the growing volume of global requirements. Tracking changes, anticipating upcoming shifts and assessing their impact on current…
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Frequently asked questions
Regulatory compliance solutions are integrated platforms that help pharmaceutical, biotech, and medical device companies navigate global regulatory requirements throughout the product lifecycle. These pharma compliance solutions provide centralized access to regulatory intelligence, CMC requirements, and safety monitoring across 200+ health authorities; providing teams with the intelligence needed to stay compliant, accelerate approvals, and reduce regulatory risk through expert-curated content, automated alerts, and AI-powered tools.
Pharmaceutical regulatory compliance solutions eliminate the time-consuming manual process of monitoring scattered regulatory sources across multiple countries. By consolidating regulatory guidelines, CMC requirements, and safety intelligence, with daily updates and AI-assisted search, these solutions help teams quickly find relevant requirements, identify compliance gaps early, and prepare stronger submissions, reducing preparation cycles and the risk of compliance issues.
AI in regulatory compliance transforms how teams access and analyze regulatory information. AI-powered regulatory compliance tools use natural language processing to instantly surface relevant guidelines, requirements, and precedents from hundreds of thousands of documents. Instead of spending hours manually searching multiple sources, regulatory professionals can ask questions conversationally and receive accurate, referenced answers in seconds, enabling faster decision-making and allowing experts to focus on strategic regulatory planning rather than information gathering.
Cortellis Regulatory Intelligence helps teams maintain compliance by providing centralized access to regulatory requirements from FDA, EMA, PMDA, and 80+ global agencies. With daily alerts on guideline changes, an AI Assistant for instant answers, and expert-curated content covering 310,000+ regulatory documents, teams can quickly identify relevant requirements, track evolving regulations, and understand compliance expectations; eliminating the manual monitoring that leads to missed updates and compliance gaps.
Cortellis CMC Intelligence helps teams maintain CMC compliance across global markets by consolidating requirements from 137 countries into standardized CTD Module 3 format with side-by-side comparisons in English. The platform provides expert-curated intelligence on local regulatory practices, submission pathway timelines, and market-specific expectations that published guidelines don’t reveal. It enables teams to identify compliance requirements quickly, prepare dossiers that meet country-specific standards, and avoid the CMC technical issues that account for 18% of regulatory delays.
OFF-X helps teams stay ahead of regulatory safety expectations by providing translational safety intelligence that enables proactive risk management. By monitoring drug class safety profiles with daily-updated data from clinical trials, FAERS/JADER, regulatory documents, and scientific literature, OFF-X enables teams to benchmark competitor safety profiles, identify emerging class-wide liabilities before regulators raise concerns, and prepare compelling risk-benefit assessments that address safety questions in submissions and health authority interactions; strengthening compliance positioning throughout the product lifecycle.
These solutions integrate to provide end-to-end regulatory support: Cortellis Regulatory Intelligence monitors global guideline changes and submission requirements, Cortellis CMC Intelligence helps ensure your chemistry and manufacturing sections meet country-specific standards, and OFF-X tracks safety signals that could impact regulatory expectations. The combination of these solutions enables teams to connect regulatory strategy, CMC compliance, and safety monitoring, supporting comprehensive preparedness for submissions and health authority interactions.
