Inspection readiness

Just in Time GCP is a clinical compliance company founded in 2005 by Donna Dorozinsky in Warrington, PA. It helps life science organizations achieve inspection readiness by aligning people, processes, and technologies with Good Clinical Practice (GCP). The company has over 60 full-time, U.S.-based clinical experts and has supported more than 100 regulatory inspections.

clinical system implementationgap assessmentGCP compliancemock inspectionsprocess optimizationremediationTMF management

Elliott Strategic Advisors (ESA) is a Service-Disabled Veteran-Owned Small Business (SDVOSB/VOSB) providing strategic advisory services for regulated and infrastructure environments. Founded by Roy A. Elliott Jr., a former U.S. Navy Nuclear Submarine Officer and NRC Senior Project Engineer, ESA advises on regulatory strategy, program oversight, operational risk, and risk-informed decision-making for energy, utility, infrastructure, and federal clients.

compliance alignmentgovernance and decision supportoperational advisoryprogram oversightregulatory strategyrisk-informed decision-making

FDA Quality and Regulatory Consultants (FDAQRC) is a provider of regulatory compliance solutions for pharmaceutical, biotech, and medical device companies globally. Its employees and consultants are experienced across all GxP areas, supporting clients at all product life cycle and development phases. FDAQRC offers quality audits, mock inspections, gap assessments, remediation services, and recruitment, pairing clients with experts through a global consultant network.

Computer System ValidationGap assessmentsmock inspectionsqualification and validationquality auditsrecruitmentregulatory affairs consultingRemediation Services

JT BridgePoint Global Clinical Solutions, LLC is an independent research consulting firm founded by Johane Telhomme, MBA, with more than eight years of experience in sponsor-funded and academic research. It supports academic institutions, investigators, sponsors, and community clinics with regulatory, quality, and clinical operations support, helping teams stay inspection-ready, accelerate start-up, and maintain high-quality data.

Community engagement in researchproject managementQuality and operational supportRegulatory Compliancetraining