Pharmacovigilance
Ensure safety compliance with services like UK QPPV/NCP, PV audits, and training. Strengthen your pharmacovigilance systems efficiently.
UK QPPV/NCP
Acting as the designated expert and point of contact for your portfolio of pharmaceutical products. Ensuring that you have a robust pharmacovigilance QMS
PV Auditing
Identify gaps, mitigate risks, manage safety monitoring and handle compliance. We can help you with preparation or implementation of CAPAs
RMM/RMP (Risk Management)
Development and implementation of risk management strategies, particularly complex RMM
SDEA (Safety Data Exchange Agreement)
Expert handling of agreements, meeting legal and regulatory obligations.
Our Services
Comprehensive Solutions Tailored to Your Needs
Leverage our trusted partners for full UK affiliate services covering all compliance functions. With a single UK contact, we streamline local compliance so you can focus on other priorities confidently.
From safety reporting to regulatory submissions, we handle every detail with precision, allowing you to operate with complete peace of mind.
Ensure safety compliance with services like UK QPPV/NCP, PV audits, and training. Manage risk with tailored mitigation plans and SDEA oversight. Strengthen your pharmacovigilance systems efficiently.
UK-QPPV
UK-NCP
PV Auditing/Training
RMP/RMM (Risk Management)
SDEA (Safety Data Exchange Agreement)
Streamline compliance with safety comparisons, SmPC/PIL updates, and reclassification strategies. Navigate regulatory processes with expert guidance for scientific advice meetings.
Reference Safety Comparisons
SmPC/PIL Updates
Reclassification/Repurposing
Scientific Advice Meetings
Optimize medical information setup, FAQs, and standard responses. Design and monitor bioequivalence studies with precision. Deliver accurate, reliable medical support tailored to your needs.
Medical Information Setup
Author FAQ/Standard Responses
BE Study Design
BE Study Monitoring
Build a stronger team with organisational strategy, design, and key personnel recruitment. Align operations for growth and efficiency. Turn your vision into actionable results.
Organisational Design
Organisational Strategy
Recruitment of Key Personnel