Our team of Regulatory Affairs services have a strong reputation for delivering fast, high quality product approval and efficient licence maintenance.
Our complete and comprehensive expert understanding of global regulatory requirements, coupled with a strong commercial awareness, ensures we devise optimal regulatory strategy for the registration of your new innovative drug, medical device, borderline product, generic medicine, line extension or additional indication.
We bring our significant expertise to strategic and operational aspects of Regulatory Affairs to guide you through the maze of global, regional and national requirements to get you product to market as quickly as possible with an optimal product label.
What we do
For medicines, our experts will advise on all aspects of drug development and regulatory strategy. It is vital to get organised and prepare target SmPCs, orphan drug applications and paediatric investigation plans, and evaluate the potential impact of your product on the environment (via an environmental risk assessment), well in advance of marketing authorisation applications. Our team is ready to prepare these for you with the application of their significant regulatory knowledge and experience, to guide you through the regulatory maze.
As part of our regulatory affairs services we will devise strategies to extend the lifecycle of your product, via duplicate licence applications, strategic line extensions and legal status switching, to ensure you gain the maximum commercial return from your products.
For devices, our experts will use their deep regulatory knowledge to advise on the correct classification of and clinical evaluation strategy for your product. Their experience is used to help you comply with all the applicable regulations and standards, to prepare technical files and design and implement a fully compliant Quality Management System.
For cosmetics, regulatory affairs team will use their expertise to position your product correctly as a cosmetic, to prepare technical files and safety assessments and to ensure you develop the best labelling and claims to maximise the sales for your product.