quality audits

ADVANCED CELL & GENE THERAPY, LLC is a consulting firm specializing in the development and commercialization of cell therapy, gene therapy, and tissue-engineered products. Founded in 2002 by Scott R. Burger, MD, it provides guidance informed by over 120 years of combined experience in manufacturing, regulatory, quality, strategic, and device aspects of these products.

analytical methods development and validationautomationclosed-system processingdue diligenceexpert witnessGMP manufacturing consultingprocess developmentregulatory submissionsscale-up/scale-outtechnology transfer

AGI International, Inc. is a CVE Certified Service Disabled Veteran Owned Small Business (SDVOSB) founded in 2003 and headquartered in Indianapolis, Indiana. It provides supply chain management (4PL), global sourcing, contract manufacturing, contract assembly, warehousing, transportation and logistics, and government office supplies. It also has a division focused on government and military support services and offers cloud-based technology support services.

4PL supply chain managementcontract assemblycontract manufacturingcontract packagingcross docking and kittingfulfillmentKaizenManufacturing engineeringpackaging designquality inspection/sortingreverse logisticsSix Sigmatool and die design/developmenttransportation and logisticstruck broker serviceswarehousing

Bracane Company, Inc. is an award-winning consultancy founded in 2002 that advances research, compliance, and strategic program management across healthcare, public, and private sectors. It partners with public and private organizations to design, staff, and manage programs, with capabilities spanning clinical operations, quality audits, regulatory compliance, training, and workforce development.

clinical operationsoperational supportprofessional placementsprogram managementproject managementRegulatory Compliancetraining and workforce development

CIS International (founded as Conde InduServices Corp. in 2010 by Dr. Carlos Conde) provides consulting, research and development, outsourcing, and training solutions focused on engineering, quality, and environmental health and safety (EHS) for regulated industries. The company also serves as a talent development and internship center and manufactures the patented Stream Sampling Kit (SSK) for real-time pharmaceutical powder quality monitoring.

3D printingconsultingenvironmental assessmentsindustrial hygienemanufacturingoutsourcingprocess validationprototypingReal Time Release TestingTraining

Ena Source is a York, Pennsylvania-based supplier of custom metal, rubber, and plastic parts for small and mid-sized manufacturers. Founded in 2023, the company acts as a single source for custom parts, handling sourcing, supplier management, risk mitigation, technical support, logistics, quality, and warehousing behind each part. It offers end-to-end supply chain management, strategic sourcing, supplier diversification, negotiations, and importing assistance.

CNC machiningcustom assembliesdual sourcingimport/customs complianceinjection moldinginventory programslogistics managementrubber moldingstrategic sourcingSupplier management

Executive Landscaping has provided commercial landscaping and snow and ice management for properties in Connecticut and Westchester County, New York since 1983. Based in North Haven, CT, it serves corporate campuses, healthcare facilities, schools, municipal grounds, industrial sites, retail centers, and HOA communities, with services including landscape management, irrigation, enhancements and installation, green roofs and plant health, and masonry repair.

aerationde-icingfertilizationgreen roofshardscapeirrigationlandscape design and installationlandscape managementmasonry repairmulchingoverseedingplant health careplowingpruningsnow and ice managementturf care

Exxel Outdoors, LLC is a leading, global provider of innovative outdoor recreational and commercial products and one of the largest privately-owned companies in the industry. It manages a family of trusted brands spanning the outdoor industry, airbeds, and urban travel, with headquarters in Broomfield, Colorado and offices and facilities worldwide.

distribution and fulfillmentindustrial designpattern makingproduct developmentraw materials sourcingsample makingsewingsleeping bag manufacturingweaving (water-jet weaving mill)

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 readinessmock inspectionsqualification and validationrecruitmentregulatory affairs consultingRemediation Services