Gnnosis is a European pharmaceutical consulting firm delivering seamless Pharmacovigilance, Regulatory Affairs and Marketing Authorization — from first-in-human studies to worldwide launch and beyond.
Case processing, signal detection, PSUR/PBRER authoring, RMP development and full inspection readiness across the European Union.
Strategy, dossier preparation, variations and lifecycle maintenance for medicines, devices, supplements and dietetics.
National, DCP, MRP and centralized procedures — we identify the right pathway and lead it to approval.
Qualified Person for Pharmacovigilance, PSMF authoring and maintenance, audit and inspection support.
Trial safety and post-marketing surveillance for original and generic companies, including Early Access programs.
Every product has a unique regulatory story. We begin by understanding yours — the molecule, the market, the timeline — before recommending a path forward.
From our trusted network of EU pharmacists and physicians, we build a team scaled precisely to the work — local where needed, global where required.
Pharmacovigilance demands precision, diligence and acute awareness. We measure success by inspection-ready files and uninterrupted patient access.
Gnnosis specialises in Regulatory Affairs and Pharmacovigilance services, meticulously tailored to the unique requirements of each client. Our team brings extensive experience spanning clinical trials and post-marketing activities.
We have collaborated with prominent Contract Research Organizations (CROs) across the European Union, serving both original and generic pharmaceutical companies. Our footprint includes successfully leading multiple worldwide launches and representing Early Access programs.
Within PV, MA and RA for medicines, medical devices, food supplements and dietetics — we orchestrate and lead teams on both local and global scales, ensuring flawless representation of our clients' interests.
Innovator and generic medicines across all major therapeutic areas and procedural routes.
MDR/IVDR pathway support, technical documentation and post-market surveillance.
Notification, claims substantiation and ongoing compliance for nutraceuticals across the EU.
Foods for specific medical purposes — formulation, labelling and authorisation.
Signal detection, benefit–risk evaluation and risk minimisation throughout the product lifecycle.
Audit preparation, PSMF maintenance and gap analyses — ready for competent authority scrutiny.
Whether you need full PV system support, regulatory strategy for a new market, or expert hands on a specific dossier — we're ready to help.