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Spectrum certified to ISO 9001:2015 Quality Assurance Standard by BSI
Spectrum Regulatory Solutions has recently been certified to the new ISO 9001:2015 standard, following a rigorous external audit to best practice measures by the global business standards company, British Standards Institute (BSI).
By: Spectrum Regulatory Solutions Ltd
"We are extremely proud to be among the first companies to have successfully transitioned to ISO 9001:2015. The transition gives us the opportunity to improve the alignment of our business objectives with those of our Quality Management System. It's a Standard that suits our business particularly well, placing emphasis on the needs of our customers and all our other stakeholders also. It enables us to engage everyone in the organisation in the task of identifying and managing the risks and opportunities that impact our business, putting us in the best possible position to provide a service that meets and exceeds customer and statutory requirements"
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. Key services include regulatory affairs and compliance across the EU, medical & regulatory writing, and readability testing. Spectrum's experience covers both medicinal products - pharmaceutical, biologicals/