Scientific Advice (SA) is one of the important interactions of the IMP owner with a regulatory agency (national or European level). It can facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients. Scientific advice can be requested at any point in the drug development process before a Marketing Authorisation Application (MAA) submission. Questions usually relate to Quality, Nonclinical, Clinical, Statistics and Regulatory aspects of development. Early advice can be an important consideration, particularly if guidelines are unclear for development of a novel therapeutic.
At Clinmark we can help our Sponsors approach EU national competent authorities (NCA) or the European Medicines Agency (EMA) with specific scientific questions before submission of a Marketing Authorisation Application (MAA). A Briefing Book will be needed to accompany any Sponsor’s questions to provide the EMA or NCA with an overview of the product and any relevant background information that is pertinent to the questions being asked. We can assist or Clients with drafting, review and finalizing a proper briefing document. We can also support sponsors by attending Scientific Advice meetings, support discussion with EMA/ NCA expert, take the company minutes at the meeting and share these after for client input and review before finalizing and sending to the agency.