EMA and HTA Bodies
The European Medicines Agency (EMA) and European Network for Health Technology Assessment (EUnetHTA) offer parallel consultation on development plans required to support decision making on marketing authorisation and reimbursement of new medicines.
The parallel consultation is a single gateway to scientific advice for regulatory purposes and early dialogues for reimbursement requirements, allowing collaborative discussions between regulators and HTA bodies and providing simultaneous feedback on evidence generation plans.
A strong interaction between regulators and HTA bodies aims at optimising patients’ access to new medicines in the European Union.
How BlueReg can support you for EMA / HTA Parallel Consultation
A BlueReg Project Manager will be assigned to your project as key contact person along with a dedicated team of highly experienced BlueReg 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, for example:
- Provide recommendation on parallel advice versus multi HTA procedure selection,
- Check the eligibility for the consolidated parallel consultation pathway,
- Review the proposed consultation strategy on regulatory, market access and writing aspects,
- Author the required documents with your input: briefing package, protocol synopsis, responses to list of issues, slide deck, meeting minutes, –
- Coordinate on your behalf the entire procedure (letter of intent, pre-submission phase, evaluation phase)
- Can represent or assist you at face to face discussion meetings, as required.
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 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 .
Scientific Advice and Interaction with Health Regulatory Agencies
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.