| |
Interpreting and understanding the requirements of Directive 2001/82
as amended and the latest EMEA and VICH guidelines is challenging
and time consuming. Whether you are interested in vaccines, antisera
or any product that is mediated by way of immune response, Cyton
will advise you on the most suitable regulatory approach.
Part II
- Biological development and manufacture: strategic advice
and support
- Planning and managing development projects
- All aspects of Part II of the dossier
- Expert Reports
Part III
- Planning safety studies: strategic advice and support
- Management of safety studies
- Preparation of Part III of the dossier
- Expert Reports
Part
IV
- Laboratory and target animal challenge studies
- Management of clinical field studies
- Experience with all target species, including fish
- Preparation of Part IV of the dossier
- Expert Reports
|
|
| |
|
|
