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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.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