NDA Management Services

Acceleration understands the complexity in designing and managing the regulatory submission. Our team works directly with the client to custom design development and validation strategies to meet the desired budget and timelines. Our team has managed more than 15 NDA level analytical programs in the past 9 years with an excellent regulatory record. In addition to providing analytical testing and validation services (all under cGMP conditions), we can assist with project management, protocol development, interpretation, comparator sourcing, procurement of ancillary supplies, and supply chain management as well as vendor management.

  • Keys to Sucess

    • Dedicated Project Leaders with
      proven track records
    • Custom design and management
      of study protocols
    • Project leadership
      o sufficient, relevant, accurate
      and consistent information
      to all stakeholders
      throughout the life of the project
    •  Regulatory and publishing
      support available
    • Post-approval and market support
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