Product Postmarketing
Our suite of end-to-end services includes support for your postmarketing requirements to ensure the quality and safety of your product. We provide drug safety and compliance services with bilingual native-speaking specialists using integrated technology to deliver regionally focused solutions that can be scaled globally based on client needs.
- Remediation
- Quality Management Systems (QMS)
- Quality Assurance (QA)
- Qualified Person (QP) and Responsible Person (RP)
- Pre-Approval Inspection and GxP Audits
- Process Validation
- Cleaning and Sterilization Validation
- Good Manufacturing Practices (GMP) Product Lifecycle Methods
- Computer System Validation
- Equipment, Utilities, and Facilities
- Bioprocess Engineering
- Process Architecture and Facility Design
- Equipment and Facility Engineering
- Process Automation
- Technology Transfer
- Process Optimization
- Program and Project Management
- Process and Product Development Management
- Third-Party Selection Services
- Quality Investigations
- Qualified Person for Pharmacovigilance (QPPV) and Local Person for Pharmacovigilance (LPPV)
- Individual Case Safety Reports (ICSR) Processing and Reporting
- Aggregate Safety Report Generation and Reporting
- Global and Local Literature Screening
- Signal Management
- Pharmacovigilance System Master File (PSMF) Development and Maintenance
- Risk Management Plan (RMP) Development and Maintenance
- Postmarketing Pharmacovigilance (PV) Auditing Services
- Global 24/7/365 Contact Center Support
- Adverse Event (AE) Intake and Follow-up Services
- Product Complaint Intake and Follow-up Services
- After Hour Services
- Standard Document Creation
- Custom Response and Content Management
- Response Document Maintenance
- Translation and Localization Services
- Promotional Review
- Congress/Booth Support
- Clinical Trial Emergency Unblinding Services
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