Market specific services and time to engage with BlueReg
BlueReg has a dedicated team of experts who cover the whole development process from concept to approval, on centralized 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)
- Pediatric 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.
Looking for support in marketing your product in France? PharmaBlue, a BlueReg company, is a partner “Exploitant” of pharmaceutical companies for the marketing in France of their medicinal products which have been granted a temporary use authorization (ATU) or a marketing authorization (MA).
BlueReg assists companies to plan and submit any necessary changes to existing marketing authorizations before the end of the Brexit transition period in order to comply with EU law. Please contact us or follow our BlueReg Linkedin page to be kept up to date with the Medicines and Healthcare products Regulatory Agency (MHRA) Brexit guidance as they are issued.