To be able to market a medicinal product in the European Union a Marketing Authorisation (MA) must be obtained for each product. The Marketing Authorisation certifies that the product meets the required standards of safety, quality and efficacy.
By the time a company is at the point of submitting a Marketing Authorisation Application large amounts of time and money have already been invested in the product. This makes it essential that the optimal route to market is chosen allowing return on investment to be achieved in the shortest possible time frame
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. By carrying out GAP Analysis before submission we can make sure that your dossiers are compliant, therefore increasing your chance of unlocking the doors to Europe early
We can publish Marketing Authorisation dossiers in either eCTD or NeeS format.