Expertise
Pharmaceutical, Biotechnology & Medical Device
Clinical
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Clinical Strategy and Operations
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Due Diligence
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Process Review, SOP Development, and Clinical Program Management
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Clinical Systems Design and Review (eTMF, CDMS)
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Biostatistics/Programming and Data Management Support
Regulatory
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Regulatory Strategy, Operations, and Communications
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Regulatory CMC and Labeling
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Submission, Medical Writing, and eCTD Publishing
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Preparation, Support, and Assistance with Regulatory Agency Interactions
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Advertising and Promotion Reviews
Drug Safety/Pharmacovigilance
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Serious/Targeted AE Review
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Safety Surveillance, Signal Detection, and Management
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Safety Issue/External Inquiry Management and Regulatory Safety Reporting
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Benefit/Risk Management (REMS) and Post-marketing Outreach Program Safety Management
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PV Auditing and Signal Detection Processes
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Clinical Trial Processes
Quality
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Audits (Investigator Site, Process, Corporate, Regulatory)
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Inspection Readiness Support and Mock Regulatory Inspections
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Regulatory Inspection Remediation
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Trial Master File Assessments and Due Diligence
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Quality System Assessments and SOP Preparation/Training
Medical Affairs
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Medical Strategy and Phase 3b/Phase 4 Studies
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Post-Market Study Planning, Design, and Execution
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Medical/Scientific Reviews and Communications
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Medical Education and Legacy Product Support
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Medical Project Management