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 and Health Technology Assessment (HTA) 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 HTA intelligence. Overcome the challenges of identifying and monitoring the latest guidelines, adverse events, and HTA outcomes and empower your teams to focus on setting your therapies up for regulatory and HTA 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.

HTA intelligence

  • Confidently prepare HTA submissions and evidence dossiers
  • Understand clinical drivers of positive HTA decisions and plan for Phase II and Phase III trials
  • Benchmark HTA agency timelines and track competitors’ access in HTA-regulated markets

Biopharma Regulatory and Compliance solutions

BIOPHARMA INTELLIGENCE | REGULATORY & COMPLIANCE

Cortellis Biopharma Regulatory Solutions, Data & Intelligence
Keep up to date with regulations, maintain biopharma regulatory compliance and make the right strategic decisions.
BIOPHARMA INTELLIGENCE | REGULATORY & COMPLIANCE

Cortellis HTA Intelligence
Ensure health technology assessment success while maintaining compliance.
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

Life Sciences and Healthcare Consulting Services
Improving patient lives by helping clients discover, develop and bring new treatments and devices to market.
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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