Comprehensive Pre- and Post-Marketing Drug Safety Services
In today’s life science product landscape, you must identify crucial safety information about your products in a timely manner. From preclinical studies to post-marketing situations, Pearl Pathways has the experience to deliver thorough clinical and post-marketed drug safety and pharmacovigilance consulting services to assist you in addressing product safety concerns.
Pharmacovigilance consultants from Pearl Pathways act with your team to support:
Clinical and Marketed Individual Case Safety Reports
Prepare regulatory-ready safety reports for clinical and marketed products, ensuring compliance with client-approved procedures from initial event capture to submission-ready regulatory forms.
Development of all clinical and marketed periodic reports for planned regulatory response.
Scientific Literature Reviews
We provide literature searches, literature tracking, and literature evaluations to support existing client safety reports.
Safety Signal Detection
Signal detection and management activities are essential for proactive pharmacovigilance. Pearl Pathways can conduct all or part of your signal detection and/or analysis.
Our consultants facilitate the development of clinical and post-approval strategies. We also provide pharmacovigilance consulting and planning services, including the development of significant clinical and marketed safety specifications and risk minimization plans.
Safety processes and SOPs
Whether setting up new processes or addressing existing procedures, our experts have extensive experience in the life science sector and provide effective recommendations to suit your business needs.
Regulatory Consultation and Communications
Pearl Pathways provides valuable regulatory assessment and strategy for product development, including regulatory filings and other consultative services (e.g., post-approval commitments, new drug application strategies and regulatory agency advisory committee meetings, annual reports).