Drug Registration

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.

 

Regulatory Roadmap

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.

Product Design

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
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Associated services

Registration Strategy

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.

Associated services

Pharmacovigilance

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.

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

Management of the geographical roll-out of a change for several products registered in Europe & the Rest of the World

A pharmaceutical company contacted BlueReg to help them manage the change of address of the Marketing Authorisation Holder (MAH). In...

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