REGULATORY AND QUALITY CONTROL
As part of our full service offer, we support our customers to develop products that are compliant in various parts of the world. We have an experienced regulatory team that follows up on local regulations so that we develop and maintain up-to-date cosmetics files.
We also provide support for claims substantiations and safety testing.
Our facility in Nottingham, UK, can produce licensed and monograph products as well as non-licensed cosmetics and personal care products.
We continuously challenge ourselves to maintain the highest quality standards. As a contract manufacturer, we also work very closely with our customers to fulfil their specific quality expectation in terms of product development and process validation.
BCM comply with the following standards:
- Drug Good Manufacturing Practice in European Council (EC):
- Directive 2001/20/EC
- Directive 2004/27/EC
- Directive 2005/28/EC
- ISO 13485 for Medical Devices
- Cosmetic Good Manufacturing Practice ISO 22716
- Council Directive 93/43/EEC
- Regulation (EC) 178/2002
- Regulation (EC) 852/2004
- Drug Firm Establishment and Registration - FDA
- The misuse of Drugs Regulations 2001 (Regulation 5)