Set Your Marketing Authorization Application (MAA) Up for Success
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) offers scientific advice to assist investigators in identifying the most appropriate way to generate robust data on the benefits and risks of their specific product(s). Although seeking this guidance is not a requirement for approval, MAA approval rates are much higher for companies who seek the EMA’s advice and follow it. Scientific advice from the national competent authorities of the individual member states can also be requested and provided.
Navigating the rules and regulations for each type of scientific advice (national and CHMP), however, can be tricky and having unfavorable advice on record can create significant challenges that can be expensive, time-consuming, and difficult to overcome.
Obtaining successful scientific advice hinges on thoroughly understanding the nuances of both the process and the expectations of the EMA’s CHMP and the national agencies. Knowing exactly what questions to ask and how to ask them are critical components for achieving successful outcomes.
Expert Guidance Through Complex Challenges, at Every Step
For more than three decades, ProPharma Group’s regulatory team has navigated clients from the planning and implementation of early-stage development through to successful registration. We understand the complexities that exist and will partner with you through every step of the scientific advice process, including:
- Preparation, submission, and interpretation – from drafting questions that will yield the specific answers you need to evaluating the implications of the advice received
- Meeting preparation, rehearsing potential scenarios, and developing a contingency plan for addressing potential weaknesses in the advice package
Over the years, we have prepared hundreds of briefing documents for our clients seeking advice on their nonclinical and clinical data packages with the EMA and national competent authorities (NCAs). Our consultants are highly experienced in leading scientific advice meetings and in steering interaction with the experts to obtain useful advice and guidance for the client to further develop their product. Furthermore, our team possesses a wealth of experience necessary to guide clients in obtaining optimal feedback related to chemistry, manufacturing, and controls (CMC), nonclinical, and clinical questions.
Our team of experts are scientists first and foremost. This passion for science, coupled with unparalleled EMA insights, allows us to ensure your study design is valid, your rationale is sound, and your goal of achieving successful market authorization is achieved.