The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) provide specific incentives to companies who are granted ODD for their product.
BlueReg can determine if your product is eligible for orphan drug designation and provide the necessary support for your European Medicines Agency (EMA) / Food and Drug Administration (FDA) application.
Drug Development Consulting & Strategy
Currently developing a new medicinal product ? BlueReg can provide an end-to-end project plan to guide you from the development of your medicinal product right through to authorization and beyond. We can provide advice and recommendations to ensure the shortest time to market by minimising any possible barriers during the development process and beyond.
Advanced Therapy Medicinal Product (ATMP)
Looking for an Advanced Therapy Medicinal Product (ATMP) classification? BlueReg can guide you to submit a classification application to Health Authorities to determine if your product meets the requirements to be defined as an ATMP.
Early Access Programs in France
Looking to reach market earlier ? You can rely on the experience and expertise of our consultants at BlueReg for providing advice and efficient implementation of your Early Access Programs projects in France .
Scientific Advice & Interaction with Health authorities
BlueReg has extensive experience in scientific advice with the European Medicines Agency (EMA) and many national competent authorities. BlueReg can assist with all competent authority meetings.
CMC Product Development
Looking for Chemistry, Manufacturing & Controls (CMC) expertise ? BlueReg ensures CMC regulatory compliance for your projects to meet regulatory agencies requirements and expectations.
Clinical Trial Applications (CTA)
Looking to outsource Clinical Trial Applications? BlueReg offers a variety of services that bring together our global clinical and regulatory expertise to simplify your journey to market. The clinical development process can be complex and can cost your organisation significant time and money.
Paediatric Investigation Plans (PIPs)
BlueReg can provide a complete PIP writing service as well as any PIP modifications through the lifecycle of the product within the EU or US.
EMA/HTA Parallel scientific advice
Looking for support with your EMA / HTA bodies Parallel Consultation? BlueReg can provide a team of highly experienced consultants specialised in regulatory affairs, market access and scientific writing. Our consultants can advise you on all steps of the procedure and author the required documents required for this important process.
The French system for preventing and managing shortages
The French regulation on the prevention and management of stock shortages of medicinal products is...
FDA GUIDANCE – COVID-19
BlueReg continues to monitor the changes in the regulatory guidance and we wish to share...