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.
Scientific advice can be requested at any point in the drug development process before a Marketing Authorisation Application (MAA) submission. Early advice can be an important consideration, particularly if guidelines are unclear for example development of a novel therapeutic.
BlueReg supports clients in the facilitation of Health Authority meetings that can be arranged for the purposes of driving decisions for drug development, introducing new and evolving scientific concepts, or in the process of submitting a new drug application or marketing authorisation application. The majority of the scientific advice meetings BlueReg supports are with the major agencies in the US and Europe, particularly in rare disease or orphan drug development.
However, there are many occasions where national scientific advice is sought in Europe and the team are able to support meetings with agencies such as Medicines and Healthcare products Regulatory Agency (MHRA) (UK), Paul Ehrlich Institute (PEI) or Federal Institute for Drugs and Medical Devices (BfArM) (Germany), French National Agency for the Safety of Medicines and Health Products (ANSM) (France) or any member state of the European Union or Switzerland.
There are a wide variety of reasons and situations that clients may wish to engage with Health Authorities and the BlueReg team have a great deal of experience in guiding you through the process, providing advice on the process and also writing briefing packages, presentations and the questions themselves.
Sponsors are particularly encouraged to initiate early dialogue with the EMA. This ensures that the appropriate tests and studies are performed, so that no major objections regarding the design of the tests are raised during evaluation of the MAA and therefore increasing the probability of a positive outcome.
FDA and EMA scientific advice support
BlueReg can help develop your scientific advice strategy to ensure that meaningful and useful advice is the achieved outcome. BlueReg efficiently liaises with the relevant regulatory authority and will manage all timelines to ensure a smooth and timely procedure. Scientific advice procedures also give the opportunity to build a good, early relationship with the regulatory authority. Implementing the advice received into the development program can greatly increase the chances of successfully bringing a product to market.
In the United States the Food and Drug Administration (FDA) provides advice and recommendations to companies during formal meetings relating to the development and review of drug or products as regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The FDA facilitates scientific advice through formal meetings requested by a sponsor or applicant and are conducted in any format (i.e., face to face, teleconference / videoconference, or written response). Three types of meetings occur with FDA staff: Type A (discuss a stalled development program or special protocol assistance), Type B (pre-IND (Investigational New Drug) or pre-NDA (New Drug Application), end of clinical trial phases or pre-phase 3), and Type C (for any other specific development subject not covered by type A or B such as Chemistry Manufacturing and Controls (CMC)).
The European Medicines Agency (EMA) is able to provide advice to support safe medicines, for the benefit of patients, at any stage of development. Companies can ask guidance and direction from EMA on the best methods and study designs to generate robust information on how well a medicine works and how safe it is, regardless of whether the medicine is eligible for the centralised authorisation procedure or not.
Scientific advice helps to ensure that companies can receive the necessary advice to help avoid major objections on design of the trials, or testing which are likely to be raised during the evaluation of the Marketing Authorisation Application. For human medicines, scientific advice and protocol assistance are given by the Committee for Medicinal Products for Human Use (CHMP) on the recommendation of the Scientific Advice Working Party (SAWP).
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 & 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.
FDA GUIDANCE – COVID-19
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EMA GUIDANCE – COVID-19
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