Tell us about your product, market, and timeline — our specialists will design a testing programme that fits.
Our scientific team will help you identify the right tests, methods, and accreditations for your product or sample.
EU-RMP and US REMS preparation, submission support and lifecycle management. Post-Authorisation Safety Studies (PASS) to characterise known risks or investigate signals identified during routine pharmacovigilance.
A Risk Management Plan is a pharmacovigilance planning document that describes the known and potential risks of a medicinal product and outlines measures to prevent or minimise these risks in the target patient population.
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Structured per EMA GVP Module V. Covers safety specification, pharmacovigilance plan, risk minimisation measures, and PASS obligations. Submitted with marketing authorisation applications and updated periodically.
US FDA requirement for products with serious risks that require additional safety measures beyond standard labelling. May include Medication Guides, restricted distribution programmes (ETASU), or communication plans.
Observational or interventional studies conducted post-approval to characterise or quantify known safety risks, or to investigate signals identified during routine pharmacovigilance.
Contact our PV team for a free consultation on EU-RMP, REMS and PASS preparation.
Download a practical testing guide tailored to your industry — checklists, parameters, and regulatory tips in one place.
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