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Research and Development

Pharma Regulatory and compliance

Stay current with the ever-changing Pharma regulatory landscape

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Roadmap from drug discovery through regulatory approval

Streamline cross-team collaboration and ensure compliance along the drug life cycle to increase your chances of positive regulatory outcomes. Overcome the challenges of identifying and monitoring the latest guidelines and empower your teams to focus on setting your therapies up for regulatory success.

Track changing legislation

Enable all biopharma regulatory and compliance teams to easily track changing legislation and monitor drug safety risks with high-quality, comprehensive regulatory,  pharmacovigilance and CMC intelligence.

Overcome the challenges of identifying and monitoring the latest guidelines and empower your teams to focus on setting your therapies up for regulatory success.

Pharma Regulatory intelligence, compliance & monitoring

Quickly understand pharma regulations and requirements across all aspects of therapy development

Prepare for inspections and understanding trends and submission requirements.

Conduct pre- and post-marketing surveillance and understand approvals.

Safety & toxicology intelligence

Identify and anticipate toxicity and safety events commonly seen in your drug class and benchmark the safety profile of competitor compounds.

Optimize risk management planning with an integrated view of FAERS, JADER and other manually curated safety data to identify and assess potential pharmacovigilance signals.

Monitor regulatory concerns and assess label information from FDA, EMA and PMDA to anticipate potential contingencies based on the assessment of similar therapies.

Cortellis Regulatory Intelligence - Pharma regulatory data & solutions

Cortellis Regulatory Intelligence

Keep up to date with regulations, maintain biopharma and medtech regulatory compliance and make the right strategic decisions

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Cortellis CMC Intelligence

Developing a drug is difficult. Going to market shouldn’t be.

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OFF-X Translational Safety Intelligence

A unique translational tool providing drug and class safety intelligence to anticipate risks and drive new competitive value

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Connect with and Expert

We’ll become your accelerator in helping you innovate with novel research and navigate the complex regulatory and commercial landscape

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Bioworld

Actionable intelligence on the most innovative therapeutics and medical technologies in development

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Get started

Talk to us about your biopharma regulatory and compliance strategy.

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Cortellis Regulatory Intelligence has provided our organization with the necessary insights to confidently comply with regulatory guidelines. It is used every day to keep us up to date and stay compliant.

Regulatory Professional Biopharma Company

Resources

Showing the value of regulatory intelligence in pharma Showing the value of regulatory intelligence in pharma
Podcast
Showing the value of regulatory intelligence in pharma

Carolyn Hynes, Director of Regulatory Intelligence at AstraZeneca, and Céline Rodier, Senior Health Policy Manager at Clarivate, how to set up KPIs and demonstrate the ROI of regulatory intelligence.

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The key to successful drug approvals The key to successful drug approvals
Webinar
The key to successful drug approvals

Developing a robust CMC strategy is challenging – not to mention the unforeseen obstacles introduced by a global pandemic. Without a sound strategy, you’ll struggle to get your drug approved and patients will be left without access to life-saving medications. Educating your CMC team and aligning your CMC strategy across the critical functions is key...

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