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Pharmaceutical, Biotechnology & Medical Device

  • Clinical Strategy and Operations

  • Due Diligence

  • Process Review, SOP Development, and Clinical Program Management

  • Clinical Systems Design and Review (eTMF, CDMS)

  • Biostatistics/Programming and Data Management Support

  • Regulatory Strategy, Operations, and Communications

  • Regulatory CMC and Labeling

  • Submission, Medical Writing, and eCTD Publishing

  • Preparation, Support, and Assistance with Regulatory Agency Interactions

  • Advertising and Promotion Reviews

Drug Safety/Pharmacovigilance
  • Serious/Targeted AE Review

  • Safety Surveillance, Signal Detection, and Management

  • Safety Issue/External Inquiry Management and Regulatory Safety Reporting

  • Benefit/Risk Management (REMS) and Post-marketing Outreach Program Safety Management

  • PV Auditing and Signal Detection Processes

  • Clinical Trial Processes

  • Audits (Investigator Site, Process, Corporate, Regulatory)

  • Inspection Readiness Support and Mock Regulatory Inspections

  • Regulatory Inspection Remediation

  • Trial Master File Assessments and Due Diligence

  • Quality System Assessments and SOP Preparation/Training

Medical Affairs
  • Medical Strategy and Phase 3b/Phase 4 Studies

  • Post-Market Study Planning, Design, and Execution

  • Medical/Scientific Reviews and Communications

  • Medical Education and Legacy Product Support

  • Medical Project Management

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