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Regulatory Affairs Support

  • Application Support for IND, DMF, NDA, 505(b) and ANDA submissions
  • Application Support for Biosimilars and Biologic submissions
  • Life cycle management and post approval changes
  • Change Control
  • Regulatory Affairs Staff Augmentation
  • eCTD Publishing and submission support for FDA and Health Canada
  • Training
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Strategic Consulting

  • Process Improvement
  • Due Diligence
  • Regulatory Strategy for US and Canada
  • Risk Management
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Quality/Compliance

  • 483 and Warning Letter Response Preparation
  • Investigations and Assessments
  • API or Vendor/Supplier Audits
  • Quality Systems Support and
  • Quality Staff Augmentation
  • Project Management/Action Plan Execution

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