Spectrum Regulatory Solutions is dedicated to providing a high quality EU regulatory affairs and pharmacovigilance consulting service to pharmaceutical and biotechnology companies world-wide.

• We supply strategic advice and implementation with the necessary expertise to ensure regulatory approval in all phases of the drug development process, whether for a new chemical entity or for routine licence maintenance.
• We provide all major regulatory affairs and pharmacovigilance services to Pharmaceuticals, Biotech, Clinical, Generics, Herbal Medicines, Consumer Healthcare, Medical Devices companies.
• We prepare documentation for regulatory submissions and pharmacovigilance activities, covering pharmaceutical, biological, generic/biosimilar, over-the-counter, herbal and advanced therapy medicinal products, as well as medical devices and borderline substances. Specialists in agrochemicals and veterinary medicine are also available to our clients.
• We know our industry and can respond rapidly to your regulatory, medical writing and pharmacovigilance outsourcing requirements by providing access to experienced medical writers, regulatory experts, and pharmacovigilance specialists.

We have a team of highly skilled, experienced consultants, whether you need quick solutions or longer term partnerships. All members of our management team have themselves worked in global pharmaceutical companies and our consultants are drawn from industry, academia, healthcare, regulatory authorities and CROs.