PharmaBees
Pharmaceuticals - , ,
PharmaBees Employees
PharmaBees Details
We are your EU partner for registration of medicinal products If requested, we can provide an Express service = standard timelines could be shortened to minimum in case of urgency. Our work successfully passed through many regulatory authorities across EU, including MHRA, BfArM and AFSSAPS. We cover Marketing authorisation of the medicinal products - Running the procedure - MAH service for non-marketed products for dossier duplication strategy - Revision of documents in dossier for the case of repeat-use Elaboration of documents needed for the registration dossier - SmPC, labelling and instructions for medical use - including Readability user testing and mock-up design (module 1.3.) - Non-clinical overview (module 2.4.). - Clinical overview (module 2.5.) - Non-clinical summary (module 2.6.) - Clinical summary (module 2.7.) PharmaBees is a dynamic and reliable company which will satisfy your needs in terms of regulatory and related services. Our team is composed of pharma professionals and every request is handled by a project manager who delivers his tasks in time. For the documents to be parts of the registration dossier, the e-CTD format is taken for granted. Moreover, we help you with completion of the dossier for EU submission in e-CTD format
