| Amethyst
provides cGMP compliant, custom, creative, and cost effective
services (4Cs) for FDA regulated activities to
increase its customers' profitability, ensure compliance, and
promote patient safety.
We are experts in the current FDA, ISO, WHO, AAMI, EU, PDA, ISPE, and USP guidelines and recommendations. Our staff is composed of engineers, software experts, and scientists.
Why choose
Amethyst?
-
Total Integration
-
4Cs Services
-
Specialists in
Calibration/Validation Program
Development
-
Expert Knowledge of Current
Regulations
-
Multi-discipline Experienced
Staff
|
|
|
Amethyst
Technologies, LLC has services to offer all entities that
manufacture parenterals or pharmaceuticals, perform aseptic
filling, manufacture medical devices, treat patients, build
laboratories, provide blood bank services, manufacture
veterinary medicines, and perform animal testing.
|
-
To
be an industry leading and market focused biotechnology and FDA
regulations compliance services provider for both private and
public sectors.
-
To
offer custom software to manage the quality program that is in
compliance with the federal regulations for electronic records.
-
To
provide “Green” professional services for the design and
creation of environmentally friendly, efficient, and productive
clean rooms and laboratories.
-
To
develop an intellectual property portfolio and product line
focused on patient safety and environmental responsibility.
|
|
