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Regulatory

Keystone Industries has a quality system in compliance with FDA’s cGMP requirements that is also certified to ISO 9001:2008 and ISO 13485:2003, governing the requirements for medical devices.

Foreign regulatory requirements

In addition, Keystone’s quality system conforms to all known foreign regulatory requirements for the products sold into those markets and activities performed. Keystone Research & Pharmaceutical products are manufactured under cGMP conditions and comply with the European Cosmetic Directive. This compliance includes the preparation and maintenance of Product Information (PI) files on all cosmetic products sold into the European Union. These files contain confidential information required under the Cosmetic Directive 76/768/EEC, including the quantitative product formulations, hazard/safety information and raw material technical data. PI files are available to European Regulatory Officials through our European Representative located in the Netherlands.

Reach

KRP understands the potential impact of EC regulation 1907/2006 (REACH) on the chemical industry in the European Community. For that reason, we have, through our only representative, completed pre-registrations for all applicable substances, ensuring our products can continue to be sold in this vital marketplace. We also have ongoing communication with our suppliers and are continually evaluating our own registration needs to confirm that our products maintain conformity with REACH regulations.