Industrial transfer
Bertin Pharma will provide you with a professional, smooth and rapide scale up and industrial transfer.
In accordance with the « Note for Guidance on process validation », CPMP/QWP/848/96, EMEA/CVMP/598/99), we propose you the following services:
-
Selection, audit of
manufacturing sites
for pilot and industrial scale batches
-
Preparation of all required documentation (specifications, validation protocol…)
-
On-site assistance
for all the manufacturing steps
-
Troubleshooting
services
________________________________________________________________
Related services
-
Preformulation & formulation
-
Equipment and Technologies
- Manufacturing & packaging
-
Quality control & dispatch of clinical supplies
- Analytical development & stability studies
- Regulatory affairs
