BlueReg has a dedicated team of experts who cover the whole development process from concept to approval, on centralised and multi-national projects. Our consultants have diverse experience ranging from regulatory strategy to operational execution and full project management support will be provided.
Services provided by our team include:
- Development strategy and advice
- Interactions with regulatory agencies
- Clinical Trial Applications (CTAs)
- Scientific Advice (European Medicines Agency and national agencies)
- Orphan Drug Designations (ODDs)
- Paediatric Investigation Plans (PIPs)
- Drug registration and registration strategy
- Marketing Autorisation Application (MAA) dossier preparation
- Post MAA regulatory maintenance
- Regulatory publishing
- Regulatory support
- Local in-country support services and regulatory support
The ability to plan and execute regulatory and registration activities can mean the difference between missing a window of opportunity to provide patients with the new product or therapy on offer or losing out on the opportunity to a competitor. BlueReg has a team of consultants able to support clients in any international market.