Idea Regulatory

IDEA specialises in providing pharmaceutical, biotech and medtech developers with Regulatory Affairs advice and EU/UK representation. We are passionate about providing the best possible results for patients. We understand the art and science of regulatory approval, cooperating with experts and authorities throughout product development, and utilise available regulatory incentives to accelerate assessment while delivering quality data for market access and regulatory approval. Our services help our clients understand, observe and maximise the regulatory environment, smoothing the path to Marketing Authorisation Approval. Our clients include: • Niche and orphan drug developers: we provide the best possible fostering of innovative drugs from a dedicated team of experts, experienced in navigating Orphan Drug Designation (ODD) applications, including joint FDA-EMA procedures • Clinicians conducting clinical trials: our services remove the burden of the regulatory process, and provide a solid foundation on which to conduct clinical trials, safe in the knowledge that your scientific work will have a specific and appropriate legal framework to underpin your published work. • Investors: we help organisations plan and execute regulatory strategies designed to assess the true potential value of products and navigate regulatory paths with the backing of a respected name in regulatory affairs. • CRO’s: we are a preferred vendor for outsourced Legal Representation, SME and ODD services for non-EU clients, and provide additional, independent regulatory advice and support Our services include: • Dynamic Regulatory Strategy Advice • Orphan Drug Applications, including joint FDA-EMA procedures • EU Representation of non-EU sponsors for CTAs, ODDs, SME status, CE marking and PIP’s • Regulatory Submissions Management • Scientific/Protocol Advice Procedures • Regulatory Writing and Dossier Preparation Contact us on: info@idearegulatory.com