Regulatory Authority Interaction & Communication
Your Regulatory Interface with Authorities and External Stakeholders
Structured communication with competent authorities is essential for resolving regulatory questions and coordinating approval activities.
Avary Consulting supports companies in preparing and coordinating regulatory interactions with organizations such as:
EMA – European Medicines Agency
FDA – U.S. Food and Drug Administration
BfArM – German Federal Institute for Drugs and Medical Devices
PEI – Paul-Ehrlich-Institut
Other national and international competent regulatory authorities
We assist with the preparation of regulatory inquiries, evaluation of authority feedback, coordination of technical and scientific responses, and implementation of resulting actions.
We serve as a coordinating interface among regulatory affairs, product development, quality management, clinical functions, and external service providers.