GXP QUALITY SYSTEMS LLC

Capabilities

We are a contract research organization that offers quality systems-based solutions across the full spectrum of GXP. We engage with Clients to conduct a review of their quality system or audit of a specific activity. Following the review/audit, we compile findings, evaluate issues, document issues and actions, and formulate recommendations for review. Discussion of the findings/recommendations normally results in agreement of priority items to be addressed, a remediation plan, a timeline for execution and steps necessary for sustainability. Our wheelhouse includes product development and strategic Regulatory consulting services, from auditing to authoring procedures and technical documents (pertaining to preclinical, CMC and clinical operations), to consent decree and warning letter mitigation and PAI/PLI preparation, to regulatory submissions and electronic publishing services. We also provide medical/technical writing and review services for clinical operations, data mgmt/biostats.