Global Risk Management
Proactive Safety Surveillance for Every Stage of the Product Lifecycle
Proactive Safety Surveillance for Every Stage of the Product Lifecycle
We develop comprehensive risk management systems to ensure proactive safety surveillance throughout the entire product lifecycle. Our approach helps identify, assess, and mitigate potential risks early, ensuring compliance with global regulatory requirements while enhancing patient safety. From risk assessment to ongoing monitoring, we provide strategic solutions tailored to your product’s unique safety profile.
Our Risk Management leads
Bill Richardson
Pharmacovigilance Physician
Bridget King
Pharmacovigilance Consultant, Risk Management
Comprehensive Global Risk Management Services
Risk Management Strategy & Development
- End-to-End Risk Management Planning – Developing a comprehensive Risk Management Strategy from pre- to post-authorisation, ensuring compliance with pre-submission meeting requirements and regulatory expectations.
- Regulatory Submission Support – Assistance with risk management strategy for Marketing Authorisation Applications (MAA), Biologics License Applications (BLA), and New Drug Applications (NDA), including post-authorisation safety study (PASS) synopsis development.
Risk Minimisation & Pharmacovigilance Activities
- Designing & Developing Risk Minimisation Measures (RMMs) – Creating tailored RMM messages and tools to mitigate risks effectively.
- Routine & Additional Pharmacovigilance Activities – Guidance on implementing post-authorisation pharmacovigilance plans.
Risk Management Plan (RMP) Authoring & Compliance
- Expert Authoring of Risk Management Plans – EU RMPs, development RMPs (dRMPs), Core RMPs, and Japan RMPs (J-RMPs).
- Regional RMP Compliance – Authoring risk management plans in compliance with country-specific regulations, including UK, Australia, Canada, Switzerland and other global markets.
- Ongoing RMP Support – Assisting marketing authorisation holders (MAHs) with the update and maintenance of RMPs throughout the product lifecycle.
Regulatory & Training Support
- Regulatory Risk Management Support – Ensuring smooth navigation of the marketing authorisation procedure in the EU and other regions.
- Risk Management Training – Providing tailored training programs to support teams in implementing and maintaining effective risk management strategies.
