Compliance and Quality Systems

In the US, the FDA is stepping up enforcement and Warning Letters are coming almost immediately after the Form 483 is handed to you.

Surprises are the most expensive way of finding system gaps. Knowing where you stand before it becomes a Compliance Deficiency that could result in a Warning Letter, loss of your CE mark, seizure or recall.

Whether you are just starting up a new business or you have a well establish program that needs to have a third party review, HTC is ready to support your needs.

We can provide you with a full Quality System tailored to your needs...not some cookie cutter set of documents but a system created for your products. Whether you are a device/IVD, pharmaceutical, biologics, biotech, dietary supplement or tobacco producer, HTC can create a globally compliant system for you.

We can provide on-site/off-site regulatory, quality, clincial and documentation personnel to get you going or identify weaknesses in your current practices.

System Documentation preparation
Gap Analysis
Pre-inspection BIMO Analysis
QSR (21 CFR 820)
cGxP (GMP, GLP and GCP) audit and systems analysis
Advertising and Promotions reviews and compliance analysis