BIOPHARMA INTELLIGENCE

Regulatory and compliance

Stay current with the ever-changing regulatory landscape

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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 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

Regulatory intelligence, compliance & monitoring

  • Quickly understand regulatory 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

Regulatory and Compliance solutions

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

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Talk to us about your regulatory and compliance strategy.

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