|
regulatory affairs |
||
| project planning & strategy: | ||
| z | feasibility advice; | |
| z | selection of the optimal regulatory strategy; | |
| z | streamlining and support from start to end. | |
| scientific writing & dossier formatting: | ||
| z | registration files (human and veterinary); | |
| z | expert reports (pharmaceutical, pre-clinical and clinical) [ask list] [ask sample]; | |
| z | marketing material; | |
| z | periodic safety update reports (PSUR) [ask list]; | |
| z | orphan drug applications; | |
| z | CE medical device dossiers; | |
| z | patient information leaflets; | |
| z | pesticide dossiers. | |
| registration activities in Europe (submission & follow up): | ||
| z | new applications (mutual recognition, national, bibliographic, generic, medicinal plants, nutriceuticals, pesticides, medical devices); | |
| z | dossier updates; | |
| z | line extentions; | |
| z | variations; | |
| z | license renewals. | |