Expert reports

Our own in-house Experts write critical summaries of Safety and Efficacy dossiers. They have a depth of experience in:

- Evaluation of user safety (part III dossier)

- Benefit/risk assesment (part IV dossier)

- Safety and efficacy dossiers overview and summaries

- Writing critical expert reports

- Contacts with European Regulatory Authorities

- Answers to lists of questions from EU agencies

Parts I, II, III and IV of veterinary registration dossiers

Anistème has a wealth of experience in writing veterinary pharmaceutical safety and efficacy dossiers and provides the following registration services:

- Management of pharmacological, toxicological, residues and ecotoxicological studies

- Conduct of clinical studies

- Parts III and IV of the registration dossier:

• reviewing the data provided by the sponsor,

• identifying and obtaining relevant bibliographic references,

• writing safety and efficacy documentation in line with Volume 6B recommendations.

Additional services for registration dossiers:

- Follow-up and shaping of Part I

- Writing of Pharmaceutical development for Part II

All submission dossiers prepared by Anistème are written and compiled in accordance with the key European regulations governing veterinary pharmaceuticals.