Science is our Business
Recent headlines have underscored the need for companies in the health care sector to adhere to stringent quality standards. The consequences of non-compliance can be severe. BTK has worldwide experience in the development and management of quality systems and in helping clients prepare for and host regulatory inspections.
Regulatory agencies look to a risk-based approach for the management of a wide assortment of process and product-related challenges. At the core of this process is a strong scientific rationale. BTK scientists and consultants are experienced in all parts of a multi-faceted industry. This gives you an edge in a competitive market place.
Here are some downladable documents:
Laboratory testing and animal testing operations are regulated by the GLP Rules. If you are new to these regulations, here is a primer:
The manufacturing, testing, and distribution of pharmaceuticals is governed by the cGMP rules. If you are new to these regulations, here is a primer:
