At BlueReg we share the passion for the development process and are motivated by the prospect of helping others with new products (pharmaceuticals, advanced therapies or medical devices) or therapeutic indications.
Product development to BlueReg means setting out a regulatory roadmap, a pathway towards approval in the target market and target therapeutic indication. It means helping clients navigate through the process of discussing their projects and challenges with regulators through Health Authority meetings, and lastly in this section, preparing a regulatory application dossier (New Drug Application or Marketing Authorisation Application) that showcases the intention of the applicant. All of which is not just about strategy but hands on support to write and prepare the regulatory submissions.
It is important to be able to makes decisions based on all the available input and data. Therefore, the sooner a project can be shared to obtain our input the better.
Our experience with other client activities can provide valuable insight to the challenges ahead. Regulatory roadmaps are developed in a similar manner to Target Product Profiles with the end in mind and regularly scrutinised and developed as more data become available.
Regulatory submission planning is a team effort with multiple inputs and stakeholders. It is preferable to develop the regulatory submission strategy early and implement a tactical action plan to ensure that deliverables are met according to expectations. Early investment in time pays dividends in the overall project timelines as it ensures all stakeholders are driving towards the same goals with the same set of assumptions.
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.
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.
Looking for Chemistry, Manufacturing & Controls (CMC) expertise ? BlueReg ensures CMC regulatory compliance for your projects to meet regulatory agencies requirements and expectations.
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 .
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.
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.
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.
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.
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.
BlueReg can collaborate with your experts to author, review and update your Common Technical Document (CTD) as required for new Marketing Authorisation Application (MAA) submissions or during the lifecycle of the medicinal product.
Our CMC Regulatory support services include everything from regulatory strategy and preparation of meetings with health authorities, assessment and preparation of regulatory documents, responses to agency questions, maintenance of products on market, regulatory compliance strategy worldwide and geographical roll out.
Bluereg has extensive experience in writing safety documents and can support you with assessing a product’s risk benefit profile for your product.
BlueReg can support you with a highly experienced team of professsionals in preparing and writing of your clinical study reports, supporting the redaction proposal and document package for submission to the EMA to comply with EMA policy 0070.