REGULATORY DOSSIER COMPILATION, PUBLISHING SERVICES
We design or develop or providing assistance for the preparation of CTDs. We develop regulatory body specific dossier for effective submission and registration of the molecules.
We provide assistance with writing response documents to authority deficiency letters/list of questions. We assist clients with updating dossier sections in response to authority deficiency letters during marketing authorisation procedures.
We manage the preparation of variation applications
REVISION OF SPC, PIL AND LABELLING
We offer several services in connection with product and patient information, including preparation, translation and revision of Summaries of Product Characteristics, labelling and PILs.
READABILITY TESTING OF PIL
It is important to make sure all your product literature has been user tested to confirm it is readily and accurately understood by patients. Leaflet testing is now a legal requirement for medicines in Europe. The goals of the PIL readability testing is to verify that the users can easily locate and understand the PIL information, and can explain it in their own words.
Each PIL is studied individually according to its own protocol.
We prepare protocols, manage PIL readability testing and we prepare the readability testing reports according to the relevant guidelines.
MARKETING AUTHORIZATION FILING AND MAINTENANCE (MAA, VARIATIONS, MA RENEWAL & TRANSFER)
We can assist in helping you to manage your regulatory procedures
We advise on the strategy for choice of regulatory procedure.
We prepare, submit and manage marketing authorisation applications
We prepare, submit and manage variation, renewal and MA transfer applications
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