Expertise

Pharmaceutical, Biotechnology
& Medical Device

Clinical
  • Biostatistics/Programming Support

  • Clinical Operations Support

  • Clinical Program/Project Management

  • Clinical systems design and review (eTMF, CDMS)

  • Data Management

  • Due Diligence

  • Process Review and SOP Development

  • Strategy

 

Regulatory
  • Advertising and Promotion Reviews

  • eCTD Publishing and Life Cycle Management

  • Labeling

  • Preparation, Support and Assistance with Regulatory Agency Interactions

  • Regulatory CMC

  • Regulatory Communications

  • Regulatory Operations

  • Regulatory Program/Project Management

  • Regulatory Strategy

  • Submission and Medical Writing Drug Safety/Pharmacovigilance

  • Benefit/Risk Management

  • Clinical Trial Processes

  • Post-marketing Outreach Program Safety Management

  • PV Auditing

  • Regulatory Safety Reporting

  • Safety Issue/ External Inquiry Management

  • Safety Surveillance & Signal Detection

  • Serious/Targeted AE Review

  • Signal Detection and Management Processes

Drug Safety/Pharmacovigilance
  • Benefit/Risk Management

  • Clinical Trial Processes

  • Post-marketing Outreach Program Safety Management

  • PV Auditing

  • Regulatory Safety Reporting

  • Safety Issue/ External Inquiry Management

  • Safety Surveillance & Signal Detection

  • Serious/Targeted AE Review

  • Signal Detection and Management Processes

 

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

  • Due Diligence

  • Inspection Readiness Support

  • Mock Regulatory Inspections

  • Quality SOP Preparation and Training

  • Quality System Assessments

  • Regulatory Inspection Remediation

  • Trial Master File Assessments

 

Medical Affairs
  • Legacy Product Support

  • Medical / Scientific Reviews

  • Medical Communications (Peer-Reviewed Publications, Advisory Boards, Advocacy Group Liaisons)

  • Medical Education

  • Medical Project Management

  • Medical Strategy

  • Phase 3b / Phase 4 studies

  • Post-Market Study Planning, Design, and Execution