Select a Region North America

Medical Communication and Pharmacovigilance

注重安全和成效,降低药物风险

药物警戒和风险管理

整合药物安全方法(比如药物警戒和风险管理),以保障投资组合的声誉。对于所有计划,从一开始就全球以专业知识和值得信赖的技术为指导。

医疗信息和沟通

通过由业内专业人士(包括医学作家、呼叫中心工作人员和药剂师)打造的成熟医疗沟通系统,建立信誉并加强与医护人员和患者的关系,从而确保提供一流的服务。

监管策略与合规

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. 

质量管理

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

了解我们如何助您实现业务新巅峰。