Orphan Drug Designations (ODD)

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.

 

 

 

Our experts

Our team can also support you through the entire application process from development, to registration and post-approval management

Marie-Caroline Leclere

Nadia Boehringer

Associated services

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.

Associated services

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.

Associated services

Early Access Programmes (ATU)

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 (ATU) projects (nominative and cohort) in France . 

Associated services

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.

Associated services

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.

Associated services

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.

Associated services

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.

Associated services

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.

Associated News

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FDA GUIDANCE – COVID-19

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EMA GUIDANCE – COVID-19

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