To be able to market a medicinal product in the European Union a Marketing Authorisation (MA) must be obtained for each product. There are four ways to achieve registration for your products:
Cambridge Regulatory Services has been guiding companies through these procedures since their inception, advising which procedure is the right one on a product by product basis and unlocking the doors to Europe
The Centralised Procedure essentially allows applicants to obtain a Marketing Authorisation that is valid throughout the EU. This involves submitting an application directly to the European Medicines Agency (EMA) where it is assessed by the Committee for Medicinal Products for Human Use (CHMP).
Our experience with EMA /Centralised Procedures is extensive and includes:
Being the integral part of key teams for several full MAA applications
Project managing the regulatory process for orphan drugs; from Orphan Drug Designation, through to CHM review and then MAA stage
Preparing and managing CHM appeals
The Centralised Procedure came into operation in 1995 and is legislated for by Regulation (EC) No 726/2004) (1).
Products manufactured using biotechnological processes
Orphan medicinal products
New active substances which are intended for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune diseases and other immune dysfunctions and viral diseases
Similar biological (“biosimilar”) medicinal products
Innovotive New active substances
Generic applications of products previously authorised via the Centralised Procedure
The CambReg Team love the challenge of providing support for products submitted via the Centralised Procedure. Projects of this nature are both rewarding and exciting. Through our many successful Centralised Applications we have identified that the key to a successful application is having the correct team in place with the right skill mix, early planning, awareness of ‘what is possible’ as well as a thorough knowledge of dossier and procedural requirements
At CambReg we can provide the full rage of support including:
One of the main advantages that CambReg has over other consultants is that its key staff have had numerous years’ experience in the regulatory arena working, some within the EU Health Authorities. In addition, as a result of CambReg’s work with other clients, it has a good working relationship with the EMA, UK, Irish, Swedish and Danish CHM members. Through CambReg’s network of EU associates it can also obtain informal advice and meetings with CHM members from all other Member States.
We have a unique insight into not only what our client needs in terms of how a project is managed but excellent working relationships with major health bodies within the EU.
With plenty of success in this area, CambReg truly is the service provider of choice for your Centralised Application.