Aerie Canal Consulting, LLC, founded by Monte Levinson, provides Regulatory Operations, electronic submission, and document management consulting services to the biopharmaceutical industry. We help clients manage complex projects so they can deliver products to market more quickly, improve quality, and reduce overtime. Aerie Canal delivers results to Regulatory Operations organizations in the following areas:

Electronic Submissions

  • Electronic submission planning and implementation
  • Electronic Common Technical Document (eCTD) conversion
  • Implementing the Electronic Submission Gateway (ESG)
  • Strategic interaction with FDA on electronic submissions

Document Management

  • Electronic Document Management (EDM) planning and implementation
  • System selection projects for EDM and publishing systems


  • Building an organization through recruiting, contracting, and outsourcing
  • Right-sizing Regulatory Operations to match product development cycles


  • Strategic interaction with development and commercial partners
  • Due Diligence activities, including electronic data rooms