EAS offers holistic and cohesive services for clients looking to submit GRAS and NDI submissions to FDA. From the assessments to design of early feasibility studies, ongoing study oversight with the Contract Research Organization, strategy meetings with FDA and the preparation and dossier submissions, EAS’ expert toxicologists, microbiologists and chemists work closely to ensure prioritization of your study needs and execution.
Choose EAS for:
- Determination of required performance outcomes and appropriate studies
- Development of study design and protocols
- Identification of an appropriate Contract Research Organization (CRO)
- Coordination of the study initiation and management oversight with the CRO
- On-going monitoring of study protocols and outcomes
- Input of appropriate data for inclusion in study reports
- Support the writing of the dossier for FDA submission
Posted in Did You Know, EASeNews.