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
BIOPHARMA INTELLIGENCE | DISCOVERY, CLINICAL & REGULATORY
BIOPHARMA INTELLIGENCE | MARKET ACCESS
BIOPHARMA INTELLIGENCE

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