Select a Region North America

Medical Communication and Pharmacovigilance

안전 & 효과 중심의 위험 저감

약물감시 & 위험 관리

약물 안전성 접근방식을 통합하여 포트폴리오 평판을 보호하는 PV 및 위험 관리를 포함시킵니다. 글로벌 전문성과 신뢰할 수 있는 기술을 활용하여 첫날부터 지속적으로 프로그램 안내를 받아보세요.

의료정보 & 커뮤니케이션

의료 전문 작가, 콜센터 인력, 약학박사 등 업계 전문가들이 동급 최강의 서비스 수준으로 제공하는 검증된 의료 커뮤니케이션을 통해 의료진 및 환자와 신뢰를 쌓고 관계를 강화해 보세요.

규제 전략 및 준법

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. 

품질 관리

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

귀사의 비즈니스를 한 단계 업그레이드 해드립니다.