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SERVICES:
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
    (DSMB)
  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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