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Interpreting and understanding the requirements of Directive
2001/82 as amended and the latest EMEA and VICH guidelines is challenging
and time consuming. With Cyton on your team you can be confident
of clear understanding and proven interpretation of the Regulations
and Directives, meaning your product is more likely to meet with
marketing approval, more quickly.
Quality/CMC - Pharmaceutical and analytical development: strategic advice
and support
- Planning and managing development projects
- Experience with all pharmaceutical forms, including feed additives
- All aspects of the Part II of the dossier, including Generic
Applications, Drug Master Files, Certificates of Suitability
- Expert Reports
Safety
- Pharmacological, toxicological and residues development: strategic
advice and support
- Management of pharmacological,
toxicological, residues and ecotoxicological studies
- Preparation of Parts III.A and III.B of the dossier
- Preparation of Maximum Residue Limits dossier
- Preparation of VICH Environmental Impact/Risk Assessments
- Expert Reports
Target Animal Safety and Efficacy
- Pre-Clinical and Clinical development: strategic advice and
support
- Management of Pre-Clinical and Clinical studies
- Experience with all target species, including fish, and all
therapeutic classes
- Preparation of Part IV of the dossier
- PharmacovigilanceExpert Reports
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