Eurocept Pharmaceuticals Holding is a pharmaceutical corporation headquartered in Ankeveen, close to Amsterdam. Its mission is to simplify the treatment relationship between medical practitioners and patients. Eurocept International, established in 2009, is the entity of the holding specialized in supplying the medicinal products of Eurocept Pharmaceuticals Holding, globally.
The business of Eurocept International
Regulatory
Eurocept Pharmaceuticals offers its partners in the Benelux a broad variety of regulatory and quality activities. Eurocept Pharmaceuticals has experience in applying for and maintaining regulatory approvals for over 150 products in National, MRP, DCP and CP procedures. Eurocept Pharmaceuticals holds a manufacturing/importer and wholesaler license. Furthermore a GMP and GDP certificate are issued by the Netherlands Health Authorities. Eurocept Pharmaceuticals supports on request EU-release and artwork creation. Eurocept Pharmaceuticals manages complaint and deviation handling. Subject to regulations, Eurocept Pharmaceuticals also manages named patient programs.
Pharmacovigilance
The Pharmacovigilance department within Eurocept Pharmaceutical manages a global PV system that complies with relevant country legislation and regulations. A non-comprehensive list of PV activities is:
• case processing;
• expedited reporting;
• global and local literature screening;
• signal detection;
• risk benefit assessment;
• PSUR and other aggregate safety report writing;
• RMP preparation and maintenance.
Both the Pharmacovigilance System Master File and the EU-QPPV are in-house. This Pharmacovigilance system is primarily used for the products for which one of the Eurocept Pharmaceuticals Holding companies holds a Marketing Authorisation. Eurocept Pharmaceutical executes state of the art Pharmacovigilance services for its in-licensing partners and for the products that one of the Eurocept companies distribute for other Marketing Authorization Holders. These services may include:
• safety information collection from the market;
• case processing;
• local literature screening;
• act as national contact person for pharmacovigilance.
Manufacturing and Supply
Eurocept International is a licenced and GMP-certified pharmaceutical manufacturer and importer. Production is managed within an international network of CMOs. Eurocept International employs an in-house secondary packaging unit that may also support re-packaging activities related to mitigating temporary shortages by means of product in foreign livery. Eurocept International QPs oversee the chain of production and perform batch release (certification). Eurocept International is a registered API Distributor in association with its manufacturing activities. Eurocept International holds a licence for importing and exporting and storage of narcotic and psychotropic medicinal products. From its site in the Netherlands, Eurocept International supplies medicinal products to destinations all over the world, with consideration of GMP/GDP conditions and customs requirements.
Out-licensing
For its global business, Eurocept International relies on its partner’s local expertise when it comes to market access, marketing, sales and local distribution. We need agile partners that get things done for patients. To accommodate partners to ensure they are ready to make the most of the potential of our products, we have developed various models on which we can cooperate. Depending on the specific market situation, Eurocept International is ready to deploy.