Safety and Vigilance
For medicinal and other healthcare products and medical devices, we ensure obligations are met in this rapidly-changing environment.
Enhanced EU requirements for safety monitoring for pharmaceuticals have added to the burden of compliance in terms of resources and expertise. Spectrum is positioned to help companies understand and meet their obligations in the increasingly complex environment created by the new pharmacovigilance (PV) legislation. Set-up and maintenance of pharmacovigilance systems, and PV writing, are specialities.
Risk management, post-marketing surveillance and vigilance for devices are part of our medical device regulatory service.
Cosmetics, Herbals & Nutraceuticals
Products in other sectors such as cosmetics, nutraceuticals and herbal remedies require greater levels of surveillance than ever before. Spectrum can help meet these requirements.