Cyton has a thorough knowledge of the key European regulations
that govern pharmaceuticals: Directive 2001/83 as amended,
Council Regulation 726/2004 and EMEA and ICH
guidelines. These lay out the data requirements and regulatory
procedures that apply in the European Union.
Quality/CMC
- Pharmaceutical and analytical development: strategic
advice and support
- Planning and managing development projects
- Experience with all pharmaceutical forms
- All aspects of the Module 3 of the CTD, including Generic
Applications, Drug Master Files, Certificates of Suitability
- Quality Overall Summary
Non-Clinical
- Pharmacological and toxicological development: strategic
advice and support
- Management of pharmacological, toxicological, and ecotoxicological
studies
- Preparation of Module 4 of the CTD
- Preparation of Environmental Risk Assessments
- Non-clinical Overview and Summaries
Clinical
- Pre-Clinical and Clinical development: strategic advice
and support
- Management of Pre-Clinical and Clinical studies
- Experience with a variety of therapeutic groups
- Preparation of Module 5 of the CTD
- Clinical Overview and Summaries
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