biotech.com
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HomeCompanyAbout UsWhy PSC?Mission StatementCustomer TestimonialsIndustry PartnersSoftwareSoftware OverviewAudit Utopia™ACE™ExpertiseExpertise OverviewOral Solid Dosage FacilitiesInjectablesDiagnostics and Medical DevicesCustom Software DevelopmentServicesServices OverviewValidationValidation Master PlansValidation Protocols / Reports / Field ExecutionComputerized Systems and Software ValidationCleaning ValidationEquipment QualificationFacility QualificationProcess ValidationUtility System ValidationShipping and Packaging ValidationTest Method ValidationCompliance Management21 CFR Part 11 ComplianceAudit ServicesCompliance Assessment and Gap AnalysisMock Inspections and PAI Readiness ReviewsProduct Recall and Corrective Action ManagementRegulatory Inspection AssistantQuality SystemsCorrective Action and Preventive Action (CAPA) SystemProcess Performance and Product Quality Monitoring System Change Management System Management Review of Process Performance and Product QualityCustomer Complaint Handling SystemDocumentation ServicesSpecificationsPolicies and PlanningStandard Operating ProceduresRecords and LogbooksEngineering DrawingsManufacturing Formulae, Processing and Packaging InstructionsProduct Life Cycle or Design Control DocumentationRegulatory AffairsPost Approval ReportsBiologics License Application (BLA) SubmissionsRegulatory Agency InteractionChemistry, Manufacturing, and Controls (CMC) Regulatory AffairsDrug Master Files (DMFs)NDA / ANDA SubmissionsTechnical ManagementCalibration / PM ProgramsContract Manufacturing SetupDatabase Design / DevelopmentData Tracking / TrendingDesign of Experiments / Statistical AnalysisTechnology / Method TransferIT Enterprise Systems for GXP FacilitiesLIMSERPClinical SystemsAdverse Event Reporting SystemEDMSSpreadsheet ManagementDatabase Management and ControlSpecialized Laboratory SoftwareComputer Controlled SystemsCalibration SystemsCompliance SystemsTrackwise™Laboratory ServicesTraining ProgramsStoreEquipment RentalEquipment SalesCareersJob PostingsBenefitsContact UsInformation Request FormWorldwide OfficesLocations and Driving DirectionsWelcome toPSC BiotechPSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance. PSC Biotech, incorporated in 1996, has been performing projects globally for over 15 years.PSC Biotech has over 358 customers in 23 different countries around the world. PSC Biotech is organized into three primary Business Units:Professional ServicesLife Sciences Software and IT (Enterprise)Life Sciences Hardware (Equipment and Instruments)PSC Biotech has offices in North America, Europe, Asia and the Middle East. We are the world's largest specialty biotech life sciences consultancy.The PSC Biotech Profession
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