25% of client activity is devoted to early Phase clinical development, from the start of non-human safety studies (GLP) through the regulatory submission for clinical trial initiation & approval. Early Phase companies are establishing compliance strategies and policies. Some Early Phase companies anticipate regulatory inspections from local authorities or targeted inspection from FDA.
50% (the majority) of client activity is devoted to Phase I–III GMP CMO clinical trial supply; development, manufacturing, and clinical trial support. Phase 3 companies are preparing for a pre-approval inspection and product approval.
15% of client activity is devoted to companies with commercial product. Aiding with all aspects of supply management. Lot release, shipment, 3PL management, CMO management, change control, recall, internal audits, or issues with their suppliers.
The remaining 10% is devoted to management of L. Reed Global QA, Inc., and the many tasks required to ensure robust dependable QA Consulting services.
