Registration Proceedings
Our experts have more than 25 years of experience in the preparation of preclinical and clinical registration documentation (for MAHs) and with the judgment of preclinical and clinical documentation. We offer:
- Communication with the state authority for national registration
- Preparation of the pharmacological, toxicological and clinical parts of the documentation
- Preparation, bibliographic replenishment and completion of whole registration dossiers
- Preparation of modules corresponding to former clinical and toxico-pharmacological expert reports
- Preparation of SPCs and package leaflets (PILs)
