BlueReg has a wealth and variety of experienced consultants who will ensure that the team provide you with valuable and realistic advice and support for your drug registration strategy.
Our team will anticipate any issues or challenges that could arise and will ensure you are prepared to overcome these.
- Advice on global registration strategy: pre-clinical, clinical, Chemistry Manufacturing and Controls (CMC), gap analysis, integrated product development planning , product positioning, legal basis, selection of registration route, due diligence, target product profile, marketing authorisation applications (US, EU, and Rest of the World) and submission planning (electronic Common Technical Documents (eCTD))
- Management of European registration procedures (National, Mutual Recognition Procedure, Decentralised Procedure, Centralised Procedure) and US registration
- National requirements at a worldwide level
- Coordination and preparation of your marketing authorisation application
- Health Authority Meetings (European Medicines Agency (EMA), EU competent authority, Food and Drug Administration) support including strategy to approach regulatory health authorities, briefing documents, rehearsals, meeting attendance and health authority interactions
- Project planning and timeline as per the planned launch sequence
BlueReg is registered as SME (Small and Medium-sized Enterprises) by the EMA and can assist and act on behalf of companies outside of EU for applications in Europe.
EMA offers EU incentives to SMEs, including regulatory, administrative and procedural assistance, fee incentives or fee reductions/deferrals, as well as other types of support.
Drug Registration and Regulatory Roadmap
BlueReg can be your preferred partner to support the registration of your medicinal product in Europe, in the US or in other worldwide countries. Our team of experts can also 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.
BlueReg can support with routine pharmacovigilance activities for early access programs, clinical trials or post-marketing
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