Originally Published EMDM November/December
2004
Industry News
Engineering Firm Adds Medical Device Compliance and Validation Services |
| AK Pharmaceuticals now offers regulatory assistance to med-tech firms. Its dedicated staff has experience with validation and compliance requirements. |
A global provider of engineering and validation services for the pharmaceutical
and biotechnology industries has extended its focus to the medical device industry.
AK Pharmaceuticals (Whiteley, Hants, UK) now offers a specialized staff
to assist medical device companies with the regulatory process.
While AK Pharmaceuticals has served the validation and compliance needs of the
pharmaceutical industry since 1995, it noted a lack in device-specific regulatory
services support. Many contractors offer services that do not account for the
differences between pharmaceutical and medical device regulations, according
to senior validation specialist Nick Payne. “We aim to change this by delivering
a dedicated service. Our trained staff has relevant experience and understands
the particular requirements of the industry,” says Payne. Bringing added
value to niche markets is at the heart of AK Pharmaceuticals’ long-term
business plan, he adds.
AK Pharmaceuticals specializes in the validation and CGMP requirements of compliant
quality systems. The firm has managed projects worldwide for such companies
as GlaxoSmith-Kline and Merck, as well as smaller firms. The company’s
technical specialists work with local resources, where appropriate, to ensure
that customer facilities satisfy all of the relevant local and federal agency
requirements.
For additional information, contact AK Pharmaceuticals, 4500 Parkway, Solent
Business Park, Whiteley, Hants PO15 7AY, UK; phone: +44 1489 614422; fax: +44
1489 614484; e-mail: pharma.business@akerkvaerner.com;
Internet: www.akerkvaerner.com/pharma.
Copyright ©2004
European Medical Device Manufacturer
