We offer both hands-on assistance and FDA liaison services, providing regulatory consulting throughout the regulatory process. From pre-IND planning and agency meetings through regulatory submissions (IND to NDA) and post-marketing activities, our services are all aimed at obtaining the earliest regulatory approval possible. The primary role of our Regulatory Operations Group is to collect and review regulatory documentation required during the conduct of clinical trials in the United States.
Regulatory Service:
Strategic Drug Development Planning and Consultation
