Small Pharmaceutical company.

Our client required full regulatory and medical writing support for an EU Scientific Advice Meeting and MAA authoring and submission

To assist with this project, we provided a team of medical writers who identified the appropriate Article 8(3) mixed marketing route.

The team were then able to lead the MAA content authoring and review, as well as conducting a thorough literature search of any new efficacy data, and incorporating post-marketing pharmacovigilance data

With our medical writing and regulatory assistance, the client was able to have successful Scientific Advice meetings and submit their MAA via EU DCP process to schedule. The client is on track to obtain MAA approval for their product.