Clinical

• ​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

• ​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

• Post-Approval Regulatory Maintenance and Labeling Updates

• Global Regulatory Submissions and Compliance for Commercial Products

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

• Post-Marketing Safety Monitoring and Risk Mitigation

• REMS Program Management and Compliance Monitoring

 
Quality

• 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

• Post-Approval Quality Management and Compliance Oversight

• Continuous Quality Improvement for Commercial Products

• Supplier Qualification and Management for Commercial Products

 

Post-Approval/Commercialization

• ​Real-World Evidence (RWE) Studies and Health Outcomes Research

• Market Access and Reimbursement Strategy

• Commercialization Strategy and Launch Planning

• Post-Marketing Surveillance and Pharmacovigilance

• Lifecycle Management and Product Line Extensions

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

• Health Economics and Outcomes Research (HEOR) Support

• KOL Engagement and Advisory Boards

• Post-Marketing Data Analysis and Publication Support