What we offer

Comprehensive solution for identification and evaluation of risks in the drug lifecycle, as well as development and implementation of risk mitigation plans and strategies (RMP and REMS) 

Who is it for

Heads of drug safety and pharmacovigilance teams 

Why it’s important

Identify new potential risks against patient safety

Develop risk minimization action plans

Ensure compliance to safety regulations

How we deliver

Process

Our team of risk management experts bring in-depth understanding of regulatory changes and global HA requirements for risk evaluation and mitigation strategies, to enable life science enterprises with:

  • Risk vs benefit, safety profile, and medical assessments
  • Risk mitigation strategies through proactive signal evaluation, selection of valid and measurable outcomes, identification of appropriate data sources, and surveillance time intervals
  • Authoring and updating of core and local RMPs
  • Development of REMS Medication Guides and educational materials/questionnaires 
  • Development, implementation, and management  of elements to assure safe use (ETASU)

What makes us different

Well trained physicians with in-depth understanding of regulatory requirements

In-built REMS platform for engaging with multiple stakeholders

Sensible design and implementation of risk minimization measures

2,500
RMPs and REMS
99
Regulatory compliance
98
Accuracy rate