Scientific advice

Depending on the developmental or regulatory problem statements at hand, it can be highly beneficial to actively seek scientific or regulatory advice from competent authorities. Drug regulatory authorities encourage the application for scientific advice when there is any ambiguity in guidelines or during critical decision points in the product development, whether it be pharmaceutical, non-clinical or clinical development phase.

Established Guidelines as well as scientific knowledge may change over time and insight in current agency thinking of actual or future developments may avoid inappropriate decisions. DADA can help in obtaining the best possible agency feedback by selecting the most appropriate European agency, by assisting in preparation and submission of the advice request package, by visiting the agency for oral explanations and by managing the entire advice procedure on the client’s behalf. In this field, DADA has extensive experience especially with EMA and Dutch, German, French, British, Danish and Swedish national authorities. If required, DADA experts can further assist in interpretation and implementation of the scientific advice response into the development plan.