Regulatory authorities may encourage the application of SA if there is a lack of clarity or hesitancy during drug development. They are typically introduced between pre-clinical and exploratory early phase clinical testing and can contribute to getting regulatory approval for studies, development programs and end products.
Our Multidisciplinary Team of Experts Help You:
- Choose the optimal time to request SA
- Formulate questions and select SA type
- Prepare and submit advice request packages/briefing books
- Arrange and attend meetings with regulators
- Interpret feedback and answer queries
SGS is recognized as the leading early phase contract research organization (CRO). Whatever you drug development plan, we will support you throughout your SA interactions with regulators.