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Medical Communication and Pharmacovigilance





業界最高のサービスを保証するため、医療ライター、コールセンタースタッフ、Pharm D(薬学博士)などの業界の専門家が提供する実績のある医療コミュニケーションシステムを通じて医療提供者や患者との信頼性を構築し、関係を強化します。


Our fast-paced industry is highly regulated – and a lack of preparation comes at a high cost. With the right regulatory and strategic guidance, you can expedite approvals, increase speed to market, and manage the unexpected. Learn more about Regulatory Consulting. 


Maintain compliance throughout the product lifecycle with the right balance of outsourced services and quality management systems. Consolidated data will help you easily evaluate your programs and make adjustments as needed to protect the safety and efficacy of our therapies.

Sample Services

  • Safety & Pharmacovigilance
    • Safety Post Marketing
  • Regulatory Strategy & Compliance
    • Regulatory Strategy, Submissions & Meetings Consulting
    • Due Diligence & GAP Assessments
    • Breakthrough, Fast-Track, Orphan/Rare Strategy & Submissions
    • Post-Approval Regulatory Support
    • REMS
    • FDA Mock Audits
    • Regulatory Training
  • Medical Information
    • Call center operations – Ready Day 1
    • Staffing by PharmDs
  • Regulatory Operations & Submissions
    • Submissions Planning & Management
    • 21 CFR Part 11 eSubmissions
    • eGateway management
  • Quality Assurance, Control & Hosted Quality System Solutions
    • Process & Resource Assessments
    • Quality Remediation
    • Policy, SOP & Batch Record Review, Preparation & Optimization
    • Quality System (QS) Development, Assessment & Optimization
    • CAPA Planning & Execution
    • Training – FDA, EU, GxP, QSR & Design Control, Validation
    • QA/QC/QE Staff Augmentation
    • Supplier & Internal Audit Programs
    • QMS/DMS/TMS Implementation & Operation
    • Hosted eQMS Solution