Early Access Programs
For some rare, life threatening conditions or those of major public interest, the early access to investigational drugs prior to regulatory approval is vital.
BlueReg can help navigate the complex environment of Early Access Programs (EAP) in the EU, we will work cross-functionally with your functional teams to ensure the correct timing of the EAP and strategically plan to avoid any possible hurdles. We have considerable experience in the arena of EAPs and can design and implement the programs on your behalf in the EU.
Learn more about early access programs and our consulting services / ATU in France below.
You can rely on the experience and expertise of our consultants for providing advice and efficient implementation of ATU projects (nominative and cohort):
- Provision of advice or responses to questions including strategy and/or positioning of ATU projects
- Preparation or review of ATU applications including the protocol for therapeutic use (PUT)
- Submission of ATU dossiers to the French National Agency for the Safety of Medicines and Health Products (ANSM) and follow up until ATU is granted
Via our in-house organization, PharmaBlue, we manage ATU programs in the following ways:
- Pre-launch activities for the management of ATU programs: setting up a dedicated ATU team (cell ATU), assigning toll-free phone / fax numbers and creation of a database for the management of the ATU
- Day-to-day management of ATU programs: Patient inclusion and follow up, validation of the pharmacist orders, processing and capturing all necessary data
- Generation and submission of ATU periodic reports
- Tailored approach to completely manage the end to end process or to complement existing supply chain
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.
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.
Orphan Drug Designations (ODDs)
Looking to apply for ODD designations ? BlueReg can determine if your product is eligible for orphan drug designation and provide the necessary support for your EMA/FDA application.
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.
Temporary Authorisation for Use (ATU) in France
A French pharmaceutical affiliate entrusted BlueReg to support them for the whole process of submission...
Implementation of a French Early Access Program for orphan drug patients in nominative & cohort program
A European pharmaceutical company entrusted PharmaBlue (a BlueReg Company) as French «exploitant» with the responsibility...