process validation

ABEC, Inc. is a trusted partner providing customized process solutions to the global life sciences industry, adding value through engineering, manufacturing, and services. It delivers bioprocess solutions for biopharmaceutical manufacturing, from process development to full commercial manufacturing, with more than 50 years of innovation and process expertise.

automation supportbioprocess engineeringelectropolishingmanufacturingmechanical polishingpreventive maintenanceretrofitssurface remediationvessel inspectionvessel modifications

AMF Life Systems provides state of the art solutions for the medical industry utilizing alternating magnetic fields in the kHz and low MHz range. Founded as a stand-alone company in 2008 by Fluxtrol, Inc., it develops systems for medical therapies and builds equipment for research use at universities worldwide, including applications for cancer treatment in animals and nanowarming of cryopreserved organs and tissues.

CAD softwarecomputer simulation servicesconsultingelectromagnetic and thermal finite element analysisinduction coil optimizationvirtual engineering

Aquestive Therapeutics is a pharmaceutical company advancing medicines through innovative science and delivery technologies. It has produced over 2.5 billion PharmFilm doses and offers a full suite of CDMO capabilities, including formulation development, cGMP-compliant manufacturing, and packaging solutions.

batch blendingcGMP manufacturingcontrolled substance handling (DEA-registered)DSCSA-compliant systemsformulation developmentPharmFilm technologyprimary and secondary packagingregulatory guidanceserialized packagingtech transfer

Astrix is a pharmaceutical technology services company that has helped life science organizations implement technologies for more than 30 years. It provides vendor-agnostic consulting, advisory, and expert services across research, clinical, regulatory, quality, and laboratory operations, including LIMS implementation, data management, and AI/ML solutions. The company states it does not sell or resell software.

AI/ML model trainingchange managementComputer System Validationdata managementeCTD publishingIQ/OQ/PQ supportLIMS implementationRIM implementationsystem evaluation and selectiontechnology transfer

AVN is a chemical and advanced systems technology company that delivers solutions to hard problems from concept to commercialization. It provides chemical product research, product development, process improvement, process safety, engineering, and manufacturing, along with advanced software technologies. Founded as a non-profit in 2003 and rebranded in 2023, it is headquartered in West Virginia with customers on six continents.

automationcatalysischemical manufacturingchemical process developmentcloud-native designcontainerizationcrystallizationGIS solutionspilot plant scale-upprocess engineeringSafety Engineeringscientific glassblowingseparationssoftware engineering

BSI Engineering is a full-service industrial engineering and design firm founded in March 2007 and named in memory of Bryan Speicher ("Bryan Speicher Inspired"). The employee-owned company has over 250 engineers and designers averaging 20+ years of experience across 14 in-house disciplines, serving industrial manufacturing clients in specialty chemicals, pharmaceuticals and biotech, renewable chemicals, food and beverage, consumer products, facilities, and aviation.

architectural servicesautomation and IT servicesBIM coordinationcivil and structural engineeringclean room operationsconstruction managementCost EstimatingElectrical Engineeringfeasibility studiesinstrumentation and controlslaser scanningmaster planningMechanical Engineeringpiping designprocess engineeringprocess safetyproject managementvalidationwaste water treatment

CANI, Inc. Cleaning & Microbial Control for Research & Manufacturing CANI is uniquely capable of handling any and all parts of your manufacturing, research, laboratory, or corporate cleaning, decontamination and microbial control needs. With over 20 years of experience, we serve the entire range of manufacturing and research facilities including basic research, laboratory animal research, pilot and clinical facilities, bulk compound production and finished products from drugs and medical devices to personal care and food products. Validated Cleaning Validated facilities are not locked in! CANI’s category of specified, scientifically selected, validated cleaning and decontamination agents can provide products so similar to your existing qualified and validated cleaning agents that they can be approved as alternates with simple change control documentation. Extensive testing or.

chemical feed equipment calibrationcleaning system designcleaning validationdecontaminationemployee trainingenvironmental monitoringmicrobial controlrisk management

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 hygienemanufacturingoutsourcingprototypingquality auditsReal Time Release Testingtraining

CTC Plastics is a U.S.-based custom compression molding manufacturer located in Dayton, Ohio, specializing in high-volume, high-performance compression molded plastic components and durable reusable plastic pallets. For over 30 years it has served OEMs and Tier suppliers with engineering, tooling, and sustainable recycled-material solutions.

compression moldingFirst article inspectionmaterial blending and testingpost-molding finishing and assemblyPPAP and Run-at-Rate approvalsprototypingtooling design and build

EEA Innovations specializes in medical device development, delivering engineering, regulatory, testing, and commercialization services. With over two decades of experience, the team has developed 10+ FDA-cleared products and operates within a QMS aligned with ISO 13485 and IEC 62304, partnering with innovators to fast-track medical technologies, software, and devices from concept to commercialization.

3D printingbiological evaluation (ISO 10993)design for manufacturingdesign transferEMC safety testingmachiningmedical device developmentmoldingpackaging designpackaging validationQMS (ISO 13485)rapid prototypingregulatory strategyrisk management (ISO 14971)software development (IEC 62304)sterilization validationsupplier qualificationusability testing (IEC 62366)verification and validation

Enterey is a life sciences consulting firm serving biotechnology, pharmaceutical, and medical device industries. It provides project, program, and portfolio management, change management using Lean and Six Sigma methodologies, data analysis and visualization with Smartsheet expertise, and new product introduction support. The company states it has spent the last 20 years helping life sciences leaders work more efficiently.

change managementdata analysis and visualizationGMP readinessLean and Six Sigmanew product introductionproject managementSmartsheet consultingsupply chain optimizationtech transfer

Foresite, Inc. is a consulting service and analytical testing laboratory dedicated to solving product reliability issues caused when electronics manufacturing process residues and other surface contaminants degrade field performance. Based in Kokomo, Indiana, the company investigates contamination on bare boards, components and assemblies, assesses risk factors for hardware in the field, and consults on manufacturing process transitions and optimization. It also offers rescue, restoration and contract cleaning services.

contract cleaningdisaster recoveryenvironmental testing and analysisfailure analysision chromatographymicroscopy/imaging/X-rayprocess audit and optimizationprocess monitoringprocess qualificationrescue cleaningrestoration cleaningX-ray fluorescence analysis

JAYCO Cleaning Technologies provides industrial parts cleaning systems and solutions for medical, optics, aerospace, and precision parts industries. The company offers process specialists, process validation for regulated industries, custom-engineered systems, and technical service across the USA. Parts washers are precision engineered and manufactured in Germany.

automation with conveyors and roboticsinstalls and repairson-site trainingpassivationpreventative maintenancerotary basket cleaningspray washingtroubleshootingultrasonic cleaningvacuum assisted cleaning

KRS Consulting provides creative healthcare packaging solutions, with expertise in the Drug, Biologic, Device, Combination Product and Cold-Chain sectors. The company oversees packaging initiatives, works with cross-functional departments and suppliers to develop and qualify package and labeling design, and acts as point of contact between contract manufacturing sites and clients to support clinical trials and commercial launches.

campaign pack-outsdesign controlsGMP documentationlabeling designline trialspackaging designprocedure developmentprocess developmentProcess mappingproject managementrisk-based qualificationvalidation activities