What we do
Our services include, but are not limited to:
- Study protocols
- Clinical study reports (Phases I to IV)
- CTD clinical summaries and overviews
- Investigator brochures and updates
- Clinical trial registry and database summaries
- Quality control checks of clinical documentation
- Clinical trial authorizations/investigational new drug applications
- Non-clinical reports
We have been involved with successful registrations in Europe (EMEA) and the United States (FDA) across a wide variety of therapeutic areas.
We have a sound understanding of current and emerging regulatory guidelines/requirements, experience in a wide variety of therapeutic areas and in-depth knowledge of non-clinical and clinical data evaluation, medical statistics and pharmacokinetics. This, combined with our quality control procedures, enables us to produce high-quality documents that meet your exact requirements.
