| |
|
| |
We offer custom-tailored Regulatory Affairs Services including:
|
| |
Marketing Authorisation Application (MAA) |
 |
NCE: normal process, fast track, orphan drug |
|
eCTD |
|
Generics |
|
Biotechnology products |
| |
Maintenance |
|
Type I and Type II variations |
|
Renewals |
| |
Marketing Authorisation transfer |
| |
Product information |
|
Local product information |
|
Patient information |
|
Abbreviated product information |
| |
GSASA questionnaire
Expert reports, overviews, summaries
Reimbursement application
Pharmacovigilance support
Strategic consulting in regulatory matters
Support in contacts with health authorities (Swissmedic, BAG)
|
| |
Talent line |
|
Ask for cost saving strategies in regulatory
affairs: + 41 44 932 30 32.
|
| |
Contact us for support in regulatory affairs.
Contact us now.
|
