Consulting Services


With the goal of providing our clients the experience and resources they need, when they need them, CRMG offers a wide range of specific project-level consulting support across medical, safety, clinical operations, and regulatory affairs disciplines. We do this by leveraging our internal experts and utilizing our broad network of proven and qualified consultants, to provide our clients with services that are tailored to meet your specific requirements.

Therapeutically, CRMG is positioned to meet the challenge of supporting our client’s product development needs across a diverse array of specific areas including, but not limited to:

  • Types 1 & 2 diabetes and associated metabolic disorders
  • Cardiovascular
  • Nephrology
  • Analgesics
  • Inflammatory disease processes
  • Allergy & respiratory diseases
  • Hematology & oncology
  • Gastroenterology
  • Infectious diseases
  • Psychiatric/CNS disorders

Our consulting network has enabled CRMG to boast a successful track record of supporting our clients with the following tasks and deliverables:

  • Providing effective and expedient clinical development and regulatory strategies
  • Providing thoughtful and comprehensive gap analyses of your existing data, development plans or existing pre-marketing dossiers
  • Providing advice on your existing clinical development plan that will help support your desired marketing claim platforms
  • Assisting in the development or drafting of your clinical protocol with clear statements that will support your rationale and objectives regarding your primary and secondary research questions
  • Providing and/or preparing regulatory agency advice and communications including briefing packages and key documentation for:
    • Pre-IND meetings
    • End-of-phase 2 meetings
    • Special protocol assessments (SPAs)
    • Orphan drug pre-submission meetings
    • Requests for special review cycle designations (expedited review, fast track, etc.)
    • Preparation of pediatric plans and protocols
    • General regulatory advice meetings (Type C)
    • Strategic CMC advice