BlueReg can be your preferred partner to support the registration of your medicinal product in Europe using one of the dedicated procedures (Centralised (CP), Decentralised (DCP), Mutual Recognition (MRP) or national procedure (NP)). Additionally, support can be provided in the US or in other worldwide countries.
Our experienced consultants will evaluate the most appropriate strategy to register your product in Europe and beyond. Full support can be provided to prepare the registration file, support with the validation phase, the Response to Questions and provide full local launch support.
Our experienced team have knowledge and expertise that spans all product types; from traditional pharmaceuticals and generics, to vaccines, biologics/biosimilars and other advanced therapies.
A complex and expensive process such as drug development requires a clear and coherent strategy from which a tactical action plan can be developed and implemented. The regulatory roadmap outlines major development milestones and success criteria, facilitates cost and timeline estimates, and provides a basis for sound decisions and project portfolio prioritisation and management. This roadmap must be developed as early as possible and is a living document that is revisited regularly. A combination of multi-disciplinary experts is required to include alternative development options or scenarios that help avoid or mitigate risks.
The roadmap provides clear direction to a program’s ultimate destination. It’s a plan that identifies critical paths and issues, mitigates risk, and optimises the overall time to a New Drug Approvallication (NDA) or Marketing Authorisation Application (MAA) filing.
Our team of experts facilitate and guide clients through the process of formulating the roadmap, provide critical review of one or more elements of the roadmap, or provide hands on operational support through authoring some or all the components.
Regulatory roadmap summary
Key elements of the planning process are:
- Development strategy
- Target Product Profile
- Non-clinical development strategy
- Clinical development strategy
- Quality and manufacturing strategy
- Overall regulatory strategy
- Market and competition analysis
- Life cycle management strategy and plan
BlueReg has a wealth and variety of experienced consultants who will provide you with valuable and realistic advice and support for your drug registration strategy.
BlueReg will help you make pharmacovigilance a more streamlined process through ongoing support and tailored feedback. We offer expert advice and bespoke consultancy to assist you with a complete range of pharmacovigilance services.
Specific Services for Europe
BlueReg has a dedicated team who cover the whole development process from concept to approval, on centralized or multi-national projects. Our consultants have diverse experience ranging from regulatory strategy to operational execution and full project management support will be provided.
FDA GUIDANCE – COVID-19
BlueReg continues to monitor the changes in the regulatory guidance and we wish to share...
News - 24 April 2020
EMA GUIDANCE – COVID-19
Given the support given to our clients in interactions with health authorities all around the...
News - 23 April 2020