You can rely on our regulatory intelligence as well as on the experience and expertise of our consultants for the success of your project.
BlueReg can provide you with an end-to-end project plan to guide you from the development of your product right through to authorization and beyond.
The services we offer include:
- Due diligence for licensing or investment decision making
- Strategic expert input and regulatory advice (Chemistry Manufacturing and Controls, non-clinical, clinical, efficacy and safety)
- Data assessment, interpretation and positioning
- Advice on global development plans (including Integration of value based pay evidence requirements), global regulatory strategy and meetings with regulators or payers
- Scientific writing of regulatory documents (EU and US): Briefing
documents for scientific advice, Orphan Drug Designation (ODD),
Pediatric Investigation Plan (PIP), Investigational Medicinal Product Dossier (IMPD) and Investigational New Drug (IND), Clinical study reports, Marketing Authorization Application (MAA) and New Drug Application (NDA) / Biologics License Application (BLA) modules and Responses To agency Questions (RTQ)
- Scientific writing of Pharmacovigilance / safety documents: Risk Management Plan (RMP), Development Safety Update Reports (DSURs) and Periodic Benefit Risk Evaluation Reports (PBRERs)
- Operational support and regulatory project management for ODD, PIP,
scientific advice, IMPD, IND, Clinical Trial Applications (CTAs), Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs) including regulatory publishing
- Development of Client-Customized Operational Platforms
Drug Development Strategy
The Consultants in our Global Regulatory Services team have extensive European Medicines Agency (EMA), Food and Drug Administration (FDA) and national Regulatory Agency experience. They can provide advice and recommendations to ensure the shortest time to market by minimising any possible barriers.
Our experts can help you understand new and existing guidance to ensure the medicinal product meets all regulatory guidelines; and support with product development strategy from early phase to the marketing authorisation submission.
BlueReg can also define effective regulatory strategies, aligned with the company’s and regulatory requirements, in order to facilitate post approval activities. Submissions can be prepared, or reviewed for deficiencies, along with a thorough gap analysis and risk assessment prior to submission to ensure that any questions that may arise from Health Authorities are anticipated and can be prepared for responses.
BlueReg can also help with Quality Control and publishing of regulatory submissions, and preparation for Agency meetings.
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 & Expanded 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.
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.
Supporting a biopharmaceutical company not established in Europe accessing SME incentives granted by the European Medicines Agency
A US‑based client entrusted the European legal representation and the application/granting of their SME status to BlueReg. BlueReg coordinated the...Learn more