validation services

Alpharma Integrated Solutions is a consulting corporation firm with consultants with over 15 years of experience within the Pharmaceutical, Medical Device, and Biotechnology Industries. Since its inception in 2008, it has focused on providing compliance solutions to the regulated industry around the globe, offering a combination of life-science-specific business, technology, and regulatory expertise for a risk-based approach to compliance.

application developmentcalibration and metrologyComputer System ValidationDatabase Administrationfacility commissioning and decommissioningHVAC validationIT securitylaboratory equipment qualificationLIMS qualificationnetwork managementregulatory compliance consultingSystem Integration

Apnar Pharma LP is a privately owned, rapidly growing pharmaceutical company engaged in the acquisition, licensing, development (ANDA), sales, manufacturing, marketing and distribution of generic pharmaceuticals, drugs, and OTC non-prescription items for the U.S. market. It is a NABP Verified-Accredited Wholesale Distributor (VAWD) compliant with Federal and State DSCSA rules.

analytical method developmentblister packagingbottle packagingdistributionformulation developmentimpurity profilingmanufacturingpreformulation studiesquality assurancequality controlRegulatory Affairssecondary packaging

ATUSA, LLC (branded Alpha Tech USA) is a team of professionals with over 40 years combined experience assisting FDA-regulated companies with full life cycle validation services. They offer validation services for manufacturing and packaging equipment, with main expertise in pharmaceutical inspection systems for particle and cosmetic defects, and they fabricate cosmetic and particulate test standards (defect sample sets or control sets).

21 CFR Part 11cleaning validationcomputer systems validationfabrication of test standardsfacilities design consultingFactory Acceptance Testsfull life cycle validationInstallation, Operation, and Performance QualificationKnapp Statistical StudySite Acceptance Tests

Bionique Testing Laboratories LLC is a Contract Research Organization with GMP FDA-registered facilities in Saranac Lake, NY, providing mycoplasma and biosafety testing services to the biopharmaceutical and life science industry for more than 35 years. It offers analytical assay development and validation via traditional culture-based methods, real-time PCR assays, and rapid microbial methods, and is a subsidiary of Asahi Kasei.

assay developmentCMC consultancyculture-based testingDNA fluorochrome staining assaymycoplasma testingrapid microbial methodsReal-time PCRregulatory and compliance consulting

E-Control Systems (ECS) provides complete wireless temperature monitoring systems, including IoT remote wireless temperature monitoring solutions for food service, healthcare, life sciences, and retail industries. Their systems are designed to be easy to install, use, and maintain, with 24/7 monitoring accessible from any computer, smartphone, or tablet.

calibrationcloud storagedata loggingHACCP compliance monitoringIoT monitoringwireless temperature monitoring

Eden Services Inc. is a Puerto Rico based company founded in 2011. It specializes in the design, engineering, and support services for process control applications and control center solutions, with expertise in mixing and agitation applications. Its staff has over 50 years of combined experience in process control solutions, process equipment, instrumentation, and control center consoles for 24/7 critical environments.

control center solutionsControl panel fabricationcontrol room designcustom PP fabricationcustom tank/vessel manufacturingdesignengineeringinstallation & commissioningmixing and agitationPreventive maintenanceprocess control applicationsprocurement & logisticsservice support & refurbishment

Engitech LLC is a construction, telecommunications, and federal contracting partner in Puerto Rico, serving private, pharmaceutical, and government sectors. It provides construction, telecom, and validation services.

constructionFederal Contractingtelecommunications