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.