mock inspections

Boretti, Inc. provides workplace safety and environmental services that help organizations gain a business advantage through risk reduction and implementing positive safety culture. The company designs, develops and implements risk and safety solutions using its A2M2 Strategy of assessment, action, measure, and monitor. It serves clients locally to globally from Visalia, California, and also serves the Hawaiian Islands.

air monitoring surveyergonomics assessmenthazard assessmentsindustrial hygieneISO 14001/45001 program developmentmicrobial (mold) surveynoise surveyOSHA inspection supportradiation surveyrisk managementsafety program developmentsafety training

Compliance Insight is an FDA regulatory and quality compliance consulting firm serving the life sciences industry. It helps businesses overseen by the FDA navigate the regulatory process, achieve compliance, and develop best practices for manufacturing drugs, medical devices, and biologics. Its specialists each offer at least 15 years of industry experience, and the firm has assisted hundreds of clients across North America and globally.

auditsCAPA plan developmentelectronic publishingFDA 483 / Warning Letter responseFDA compliance consultingFDA submissionsgap analysisGCP servicesGMP servicesinspection preparationproject managementquality systemsregulatory affairs trainingregulatory strategiesroot cause analysisStaff augmentationvirtual quality assurance

Cruger Consulting Services provides independent compliance consulting and training for regulated industries, including ATF compliance support for Federal Firearms Licensees and Federal Explosives License applicants and holders, and FCC communications planning, federal licensing, and infrastructure support. It also offers business services such as bookkeeping, payroll and contractor tracking, Texas sales tax reporting, corporate secretary services, registered agent services, and notary services. FAA compliance consulting is planned and not yet available.

Bookkeepingcable fabricationcompliance consultingcorporate governanceInfrastructure optimizationnetwork setupnotarizationPayroll coordinationpolicy developmentregistered agent servicesTexas sales tax filingtraining

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 complianceInspection readinessprocess optimizationremediationTMF management

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 assessmentsInspection readinessqualification and validationquality auditsrecruitmentregulatory affairs consultingRemediation Services