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Product Development Management

We offer a range of regulatory services and our philosophy is to work with you early in the development process in order to build a solid foundation leading to efficient global regulatory submission and approval.

Our services include:

  Protocol writing for Phase I IV clinical trials
  Provision of project leader or project manager, to lead an individual study
     or a complete development program of studies
  Supplier management and liaison
  Set-up, management and membership of Data Safety Management Boards
  Medical writing
  Medical monitoring
  Provision of data management and biostatistics services
  Identification and ongoing liaison with Key Opinion Leaders and investigators
  CRF/patient materials medical review
  Non-interventional trial design

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