|
|
 |
Services
| Regulatory
Affairs
Our
regulatory experts possess an astounding wealth
of knowledge, enabling us to offer quality regulatory
and clinical development services for the pharmaceutical
and biotech industries.
Our services include:
-
Preparation
of clinical trial applications
(CTA, IND)
-
Common
Technical Document preparation (CTD)
-
IMPD
(Investigational Medicinal Product Dossier)
and Orphan
Drug Applications
-
Clinical
development plans and strategic consultancy
-
-
Interaction
with gene therapy, viral and environmental
committees (RAC, GTAC, CGB, CGO, VSC)
-
Preparation
of product licence applications (NDA,
MAA)
|
|
|
 |
|
|