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