Convergence is a network of complementary service providers specializing in medicinal products & devices development, partnering to offer integrated support all along the development of your product, from global strategy to local implementation.
A network of complementary service providers specializing in medicinal products & devices development, partnering to offer integrated support all along the development of your product, from global strategy to local implementation.
Accessing the European market is a challenge for non-European companies developing and commercializing drugs, biologics, medical devices, combination products, gene- and cell-based therapies, tissue-engineering products, or cosmetics.
Our joint holistic approach will enable you to identify strategies within the complexity of regulations at both European and national levels. We help you make the relevant and consistent choices from pre-clinical to distribution, through clinical development and health economics. Based on common scientific and therapeutic grounds, the Convergence network bridges cultural differences between EU countries towards compliance with existing regulations and anticipation of forthcoming changes.
The Drugs & Devices Convergence Research Organization is a European Network of Expertise aiming at driving the product from its design to life cycle phases.
Clinical development – Data management – Biostatistics – Medical writing – Risk management – Pharmacovigilance and medical device vigilance & Haemovigilance
ADME, Pharmacokinetics – Physicochemical determination – Early formulation – Stability testing and regulatory in vitro toxicology assessment
Preclinical disease models with high translational value – Pharmacological in vivo tests and in vitro assays for (re-)profiling drugs – Safety evaluation - from early discovery to regulatory submission (GLP)
Innovative regulatory strategies – Regulatory submissions – Quality system support – Due diligence & representation of non-EU SMEs – Risk management – Pharmacovigilance, Medical device vigilance & Haemovigilance
Business Strategy and Implementation: Pre-market assessment, bottom-up approach – In-market presence – Market Intelligence – Distributors management & collaboration – Local implementation of marketing strategy