Streamline data.
Ensure compliance.
Scale up your business.
The dynamic regulatory landscape can pose significant safety and business challenges for a variety of pharma and biotech companies, no matter the size who are looking to:
- Move a product from clinical to post approval
- Advancing into multiple rest of world markets (ROW)
- Centralize their safety across a portfolio of Clinical Phase II/III studies and multiple Clinical Research Organizations (CROs)
- Make Prescription Drug User Fee Act (PDUFA) filing in the next few months for new products
- Onboard a full-service Pharmacovigilance partner
- Partner with specialized partners who help with capacity expansion
Key Benefits
- Driving new market entry through an integrated Pharmacovigilance system
- Managing and integrating multiple mergers and acquisitions (M&As) efficiently
- Expedited go-live to support and stabilize Pharmacovigilance for a leading Biotech company
- Flawless transition and rapid ramp-up of Medical Information operations to support business growth
- Delivering High-Quality RMPs and Rapid RMM Implementation for Global Regulatory Compliance
Explore Our Case Studies:
Global Pharmacovigilance, Comprehensive Safety
Maximize regulator confidence; Optimize safety compliance
Enhance patient safety with our robust case processing, aggregate reporting, and signal management solutions. Increase regulator trust, and support market access through comprehensive, timely and accurate reporting while improving operational efficiency.
Risk Management and REMS
Mitigate risks with REMS and Risk Management
Unlock full market potential of your products by harnessing our expertise in developing Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). Our strategic advice empowers you to navigate regulatory complexities across therapeutic modalities.
Integrated Medical Information
Real-time Medical Information support to your Patients and Health care Professionals (HCPs)
Provide best-in-class support to your patients and HCPs with our 24×7 integrated response center offering support in 100+ languages through customizable, end-to-end Medical Information services.