News By Tag
News By Location
Spectrum appoints Medical Devices expert Karen Cornelius
Spectrum Regulatory Solutions, a company that provides a full-service consultancy to the healthcare industry, continues its expansion by appointing Karen Cornelius as Regulatory Project Manager for Medical Devices.
“I am delighted to join Spectrum’s regulatory affairs team and promote their medical device and device/drug combination service offerings”, said Karen Cornelius. “We can help clients to negotiate the regulatory issues and clinical trial challenges when taking a device or combination product to market.”
“We are very pleased to welcome Karen and the knowledge that she brings to Spectrum” added Dr Angela Gisby, Managing Director. “I know that her expertise in regulatory strategy and clinical development and medical devices will be invaluable.”
Spectrum Regulatory Solutions was established in 2005 and provides a full-service consultancy to the healthcare industry. Uniquely, this comprises a suite of services which support manufacturers both during the run-up to obtaining marketing approval, and in post-marketing activities. These services include regulatory affairs, medical writing, safety and vigilance, market access, readability, quality assurance and compliance. Spectrum’s experience covers both medicinal products – pharmaceutical, biological, OTC, cosmetics, herbal and nutritional – and medical devices.