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One of the largest challenges, which a pharmaceutical company encounters, is faced during the few months preceding a MAA submission or a significant drug development undertaking.
With often millions in resources invested up until this period, it is imperative that the health authorities are presented with documentation that is accurate, clear and concise, besides meeting regulatory requirements.
Not all companies have the resources in-house to meet this special challenge.
I am a freelance medical writer offering expertise in English language scientific communication, in particular the preparation of the clinical dossier for MAAs.
In addition to the actual writing, my role is to help clients to plan and coordinate their scientific documentation with processes that ensure high quality and reliable timelines. |
