Pharmacovigilance, MedComm & Quality

Reduce Risk by Focusing on Safety & Effectiveness

Regulatory Strategy and Compliance

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.

Quality Management

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.

Pharmacovigilance & Risk Management

Integrate your approach to drug safety, including PV and risk management to safeguard your portfolio’s reputation. Use our global expertise and trusted technology to guide our programs from day one and beyond.

Medical Information & Communications

Build credibility and strengthen relationships with your healthcare providers and patients through a proven system for medical communication, delivered by industry professionals, including medical writers, call center staff and Pharm-Ds – all to ensure best-in-class service.

Our Products & Services

  • 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
  • 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
  • Medical Information
    • Call center operations – Ready Day 1
    • Staffing by PhDs
  • Safety & Pharmacovigilance
    • Safety Post Marketing

Find out how we can take your business to the next level.