Our Services

Develops end-to-end Risk Management Plans (RMP) and tailored risk minimisation strategies to ensure regulatory compliance and patient safety throughout the product lifecycle. 

Authors and reviews core Clinical Safety modules for licensing applications, including CTD Modules 2.5 (Clinical Overview) and 2.7.4 (Summary of Clinical Safety), as well as Efficacy and Pharmacology summaries for EU MAA and US NDA submissions.  

Provides senior Qualified Person for Pharmacovigilance (QPPV) representation, expert medical direction, and strategic leadership for pharmacovigilance teams. 

Designs, builds, and optimizes Pharmacovigilance systems, including full creation and maintenance of the Pharmacovigilance System Master File (PSMF) and associated process development. 

Provides senior Qualified Person for Pharmacovigilance (QPPV) representation, expert medical direction, and strategic leadership for pharmacovigilance teams. 

Executes robust signal detection, signal assessment, and structured Benefit/Risk evaluations to continuously monitor asset safety profiles. 

Conducts thorough medical and safety evaluations of pharmaceutical assets and PV systems during mergers, acquisitions, and in-licensing deals, ensuring smooth system integration post-closure .

Delivers expert medical monitoring and oversight for clinical development programs and Post-Authorisation Safety Studies (PASS) design and reporting. 

Prepares organisations for regulatory audits and inspections through rigorous system evaluations, gap analyses, and mock inspection scenarios.