|
![]()
| Providing Quality & Validation Services for the Pharmaceutical, Medical Devices, Biotech and other industries within North America, Europe, Asia, Australia, and other areas of the world |
| |||||||||
| ||||||||||
For the Client | ||||||||||
| ||||||||||
Pharmaceutical / Medical Devices / Biotech Regulatory
21CFR Part 11 (ERES)
21CFR Part 58 (GLP)
21CFR Part 821 (QSR)
21CFR Part 211 (GMP)
Fed. Std. 209E (ISO TC 209-14698)
European GMP
91/356/EEC, 2003/94/EC, 91/412/EEC
Military Standards
ANSI ASQC Z1.4 and ANSI ASQC Z1.9-1993
MIL-STD-105E
Safety and Environmental
Cal - Proposition 65
Cal and federal OSHA safety reg's (29CFR and Title 8)
Local and federal DEA reg's (40CFR)
ISO 9000:2000, 9001:2000 (millennium)
EU / CE Mark / UL / MDD / IVDD
[Free Documents] [Careers] [Free Process Capability]
Send mail to webmaster@qualityleader.com with questions or comments about this web site. Web Optimization by PSE. |