Advance Regulatory Consulting

Follow us for the latest regulatory insights and strategies << Advance Regulatory Consulting is an enterprising and innovative regulatory consultancy to the pharmaceutical and biotechnology industries, by supporting product development and regulatory affairs activities. Collaboratively, our quality and regulatory experts guide and drive your projects every step in the complex journey from early development to commercialisation and post-marketing activities. A journey made simple with our sound industry experience, strategic excellence, proven problem solving, and passion to bring molecules to cure. Based in London, UK, with a high-quality regulatory solution that a has global reach - we are ready. We are here to advance your ambitions. Accelerating Innovation | Delivering for Patients Our experts have regulatory affairs experience, covering the whole medicinal product lifecycle (clinical trial applications, new drug applications (MAA, NDA, BLA) and post approval variations) for ATMPs, biologicals, vaccines, medical device combinations, consumer healthcare products (OTC), small molecules and generic products in global and generic pharmaceutical companies and regulatory authorities. We have delivered multimillion dollar regulatory approvals for global pharmaceutical companies such as GSK, MSD, Bayer and Biogen for submissions in the EU, US, UK and rest of world markets. Some of Our Feedback 'They are highly capable and knowledgeable Regulatory Professionals and would be a benefit to any team.' Director, MSD 'They are talented regulatory professionals, they understand and interpret the regulations well and are excellent technical writers' Director, GSK 'Their leadership, CMC regulatory expertise, and operational awareness have been invaluable in helping the team remain on track to completing the IND submission.' Director, Biogen We look forward to helping you achieve your regulatory objectives Contact our experts: contact@entrytoregulatory.com