Registration to European standards
Our regulatory affairs and pharmacovigilance team prepares CTD dossiers in line with European legislation, documenting the safety and efficacy of every product as verified by independent authorities.
Our process: dossier preparation (efficacy, safety and quality data in CTD format) → application under the national or mutual-recognition (MRP/DCP) procedure → post-approval pharmacovigilance monitoring and periodic safety update reporting (PSUR).
To obtain up-to-date information on the registration and authorisation status of specific products in Europe, the target countries and export conditions, contact us. Our regulatory team will share the product and documentation details appropriate to your market.