Services for Pharma and Life-Science

 

 

useful tools and information

 

 

HPLC SIMULATOR

Optimize your isocratic HPLC separation using our free online HPLC Simulator. By clicking the HPLC-Simulator cube you get to the HPLC Simulator (in English, German and French).

DOWNLOADS

Currently, he following document can be downloaded:

LINKS
ANSM French Health Products Safety Agency
(formerly AFSSAPS)
BfArM German Federal Institute for Drugs and Medical Devices
EDQM European pharmacopeia
EMA European Medicines Agency
Eudralex GMP guidelines and annex
EudraPharm Database for EU medicinal products
MHRA British Medicines and Healthcare products Regulatory Agency
Paul-Ehrlich-Institut (PEI) German Regulatory Agency, part of the Ministery of Health
   
21 CFR 210 cGMP guideline of FDA for drugs and pharmaceuticals
21 CFR 211 cGMP guideline of FDA for drugs and pharmaceuticals
21 CFR 820 GMP guideline of FDA for medical devices
CDER Center for Drug Evaluation and Research (part of FDA)
FDA US Food and Drug Administration
FDA Guidance List List of FDA guidance documents (pdf-file)
FDA Inspection Guides Guidelines for FDA inspectors
FDA Newsletters Registration for the FDA newsletters
FDA Warning letters Warning letters and responses
 
Health Canada Canadian Federal Department for Health
ICH International Conference on Harmonisation
ISO International Standards Organisation
ISPE International Society for Pharmaceutical Engineering
OECD Organization for Economic Co-operation and Development
PIC/S Pharmaceutical Inspection Cooperation Scheme
PMDA Pharmaceutical and Medical Devices Agency (Japan)
USP United States Pharmacopeia
WHO World Health Organisation