Regulatory Affairs

Spectrum Regulatory Solutions provides a bespoke regulatory affairs consultancy service tailored to all levels of requirement, from high-level strategy to helping with unexpected demands on resources.

We have expertise in all the major therapeutic areas of medicine and types of product, including pharmaceuticals, biologicals, generics/biosimilars, over-the-counter, herbal and advanced therapy medicinal products, as well as medical technologies and borderline substances. We can also supply specialist skills in agrochemicals and veterinary medicine.

Our team of professionals has experience gained in pharmaceutical companies and CROs of all sizes, as well as interaction with regulatory authorities worldwide. They are equipped with all the necessary organisation, communication and negotiation skills. Fast and innovative response to problem-solving is standard, but pro-active avoidance of the pitfalls brings added value to our service. We have expertise in pre- and post-marketing registration requirements, global marketing authorisation applications, variations and renewals.

Together we can provide:

• Guidance on strategy and development
• CMC, non-clinical and clinical data packages
• PIL readability testing
• Advice on requirements and planning for registration in Europe: submissions for centralised, decentralised, mutual recognition or national routes of filing
• Liaison with National Competent Authorities; responses to questions
• Orphan medicinal products: application for designation
• Paediatric Investigation Plans (PIPs) and Paediatric Use Marketing Authorisations (PUMAs)
• Changes in legal status
• Due diligence activities in relation to dossiers and licence acquisitions
• Compliance

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