Registration Strategy

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.

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.

Associated services

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.

Associated services

Pharmacovigilance

BlueReg can support with routine pharmacovigilance activities for early access programs, clinical trials or post-marketing

Associated services

Regulatory Affairs Consulting EU

Our team composed of global experts from the pharmaceutical industry provides the necessary support to help you succeed in all regulatory aspects of life sciences in Europe from development, registration through to commercialization.

Associated services

Specific Services for the United States

BlueReg consultants can help navigate FDA regulations and provide support and advice for all your project requirements

Case study

Support for a hybrid application in the European Union

BlueReg was involved in the review of a Hybrid Application for a medicinal product in Ophthalmology to be submitted to...

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