If you want to find about the new regulatory requirements in Europe and USA, we recommend the following websites to you: 

https://www.hma.eu/cmdh.html

EDQM:

EudraGMDP:

http://eudragmdp.ema.europa.eu/inspections/logonGeneralPublic.do

https://www.bfarm.de/DE/Home/home_node.html

HORN Pharmaceutical Consulting
CMC – GMP – Regulatory Affairs
Dr. Hiltrud Horn
Am Alten Schloß 1
D-76646 Bruchsal
Germany

Phone: +49 (0) 7251/305 527
Fax: +49 (0) 7251/305 528
Mobile: +49 (0) 160/5834 213
e-mail: info@horn-pharma.de
Internet: www.horn-pharma.de