BIOPHARMA INTELLIGENCE

Pharma Regulatory and compliance

Stay current with the ever-changing Pharma regulatory landscape

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Pharma Regulatory and compliance

Streamline cross-team collaboration and ensure compliance along the drug life cycle to increase your chances of positive regulatory outcomes.

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.

Roadmap from drug discovery through regulatory approval

Pharma Regulatory intelligence, compliance & monitoring

  • Quickly understand pharma regulations and requirements across all aspects of therapy development
  • Prepare for inspections, understand trends in drug approvals and discern submission requirements and instructions
  • 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.
  • Monitor regulatory concerns and assess label information from FDA, EMA and PMDA to anticipate potential contingencies based on the assessment of similar therapies.
  • Optimize risk management planning with an integrated view of FAERS, JADER and other manually curated safety data to identify and assess potential pharmacovigilance signals.

Biopharma Regulatory and Compliance solutions

BIOPHARMA INTELLIGENCE | REGULATORY & COMPLIANCE

Cortellis Regulatory Intelligence - Pharma regulatory data & solutions

Keep up to date with regulations, maintain biopharma & MedTech regulatory compliance and make the right strategic decisions.
BIOPHARMA INTELLIGENCE | DISCOVERY, CLINICAL & REGULATORY

Cortellis CMC Intelligence
Developing a drug is difficult. Going to market shouldn’t be.
BIOPHARMA INTELLIGENCE

OFF-X Preclinical and Clinical Safety Intelligence
A unique translational tool providing drug and class safety intelligence to anticipate risks and drive new competitive value
CONSULTING & SERVICES 

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We provide strategic guidance, professional services, custom data and transformative intelligence across the healthcare ecosystem. Our teams fuel innovation in R&D, Commercial Strategy, Evidence, Value and Assessment and Technology enablement.
BIOPHARMA INTELLIGENCE | MARKET ACCESS

Health Economics and Value
In a constantly shifting health landscape, overcome ​ hurdles to gain access globally
BIOPHARMA INTELLIGENCE

BioWorld
Confidently monitor the life sciences industry news and analysis

Resources

Article 

Showing the value of regulatory intelligence in pharma [Podcast]
REPORT

How can we improve identification of toxicology-related risks in drug discovery?
ON-DEMAND WEBINAR

The key to successful drug approvals

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