International and U.S. companies rely on the expertise and professional resources of PDG to provide dependable, accurate and compliant drug safety programs, pharmacovigilance services and ongoing assessments of labeling accuracy and completeness.
An Experienced Post-Marketing Safety Surveillance Team
PDG’s array of epidemiologists, clinicians, statisticians, and regulatory experts deliver evidence-based analyses to address the safety and ongoing benefit/risk assessments of your drug products. Our services are predicated upon years of successful industry experience and regulatory interactions relating to both generic and brand name products.
Turnkey Solutions for Post-Marketing Surveillance of Drugs
PDG provides turnkey solutions that include design and implementation of critical standard operating procedures, validation, training, quality control, and quality assurance. PDG safety surveillance activities may include:
- Individual Case Reports
- Safety Database
- Safety Reports
- Literature Searches
- Safety Signal Detection
- Risk Management Initiatives