PSC Biotech is global life sciences technology company serving customers in North America, Europe, Asia, South America and the Middle East. Our 400 plus employees provide professional technical services such as commissioning, qualification, project management, regulatory affairs, quality, compliance, conceptual engineering, business analysis, Information Technology, Information Systems, calibration, computerized system validation, etc., to life science, pharmaceutical and software companies.
PSC has implemented and validated installations of nearly every enterprise GxP application for our life science industry clients from simple Microsoft Excel® Spreadsheet to enterprise information technology systems such as SAP® and ORACLE®. PSC offers managed services for a variety of enterprise applications used by the life sciences industry.
PSC Software develops, deploys and supports our world class enterprise quality management software Adaptive Compliance Engine (ACE®) and our AuditUtopia® regulatory inspection software. PSC Software provides all our clients including large multi-national operations with free version upgrades, implementation services and global, follow-the-sun support.
BioTechnique, our contract manufacturing facility in Madison, Wisconsin, manufactures sterile injectable products. BioTechnique provides cGMP compliant contract manufacturing for high value, life-saving therapeutic products. BioTechnique is actively producing drugs to meet the ongoing drug shortages in the American market. BioTechnique also works with major global charities to manufacture safe, effective and cost-competitive medicines. BioTechnique has the specialized expertise in nanotechnology, high-potency drugs, oncolytics and vaccines to take on even the most challenging manufacturing engagements.
PSC provides metrology services and NIST traceable calibrated equipment rentals. PSC metrology provides a full range of services from turnkey, full service validation programs or one-off projects.
PSC represents selected equipment manufacturers who provide world-class life science manufacturing equipment such as controlled rate freezers, low back-pressure HEPA filters, etc.
Whatever your company needs, whether you need services, software or equipment, PSC has a cost effective, fully compliant solution for your company.
PSC Biotech has five unique divisions within the parent company – each representing one of our areas of expertise: PSC Software, PSC Biotech Pte Ltd. (formerly PSC Asia), PSC Investments and BioTechnique. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
- Professional Services
- Life Sciences Software and IT (Enterprise)
- Life Sciences Hardware (Equipment and Instruments)
PSC Biotech has offices in North America, Europe and Asia. We are the world’s largest specialty biotech life sciences consultancy.
The PSC Biotech Enterprise Software and IT Business Unit mission is to perform all the necessary activities required to successfully implement an enterprise GxP IT compliant software application globally across multiple sites and multiple time zones. Activities PSC Biotech typically performs include:Click to Read More
- Business Analysis
- User Functional, and Configuration Requirement Specifications
- Risk Assessments (FMEA, FTA, HazOp, Ishikawa (Fish bone), and HACCP etc.)
- Enterprise Software Implementation
- Software Application Hosting
- We host 10 American and European Fortune 500 companies with enterprise software applications out of our Irvine, California datacenter.
- Software Project Management, Computerized System Validation and Software Training
PSC Biotech has its own software development team that builds enterprise software applications for auditing and compliance including:
All the software we develop conforms to 21 CFR Part 11 Food and Drug Administration regulations. PSC Biotech follows a comprehensive Agile software development lifecycle and has been audited by numerous pharmaceutical, medical device, biotech and diagnostics manufacturers over the past five years. PSC Biotech has several other projects under development.
PSC Biotech also hosts enterprise software in a secure, validated environment for many clients including five of the top fifteen pharmaceutical manufacturers. Applications that PSC Biotech hosts for its clients include:
- Adverse event systems
- Audit systems (ACE Auditor)
- Electronic content management systems
- Enterprise resource planning systems (ERP)
- Inspection systems (ACE Inspection)
- Laboratory information management systems (LIMS)
PSC Biotech has successfully deployed many global enterprise global systems including:
- Adverse Event Systems
- Clinical Databases
- Clinical Voice Response Systems
- Corrective and Preventive Action (CAPA)
- Genomics Software
- Laboratory Information Management Systems (LIMS)
- Metrology / Calibration / Maintenance / Asset Management Databases
- Multiple Vendors
- Process Control Systems
- Allen Bradley™, Delta V™, iFix™, Siemens™ and other GLP and GCP applications.
- Quality Management Software
- Multiple vendors including TrackWise™ and Pilgrim™
The PSC Biotech Hardware and Equipment Business Unit distributes equipment used in the pharmaceutical, medical device, biotechnology and diagnostics industries. PSC Biotech has installed, commissioned and validated this equipment in facilities worldwide. Equipment distributed by PSC Biotech includes:Click to Read More
- Climet™ particle counters
- Climet™ facility monitoring systems
- Vapor Hydrogen Peroxide (VHP) Sanosil™ sterilization systems
- WFI Stills, Deionized / Purified Water Systems
The Hardware and Equipment Business Unit’s mission is to provide the best instrumentation and equipment that meets our customer’s User Requirements and to provide the necessary support and service to ensure worry-free operation over the instruments and equipment life time. The Hardware and Equipment Business Unit includes a Metrology division that has an ISO 9001:2008 certified calibration laboratory. The Metrology group can calibrate Climet™ particle counters, GE Kaye™ 2000 Validators™, Shortridge™ Hoods, pressure and temperature measuring instruments. PSC Biotech has all equipment calibrated to NIST traceable standards, and our all of our equipment is qualified per internal PSC protocols. PSC Biotech has a validated, calibration database for managing GxP instruments.
PSC Biotech Hardware and Equipment Business Unit rents GE Kaye Validator 2000, Climet™ particle counters, and can fabricate thermocouples (Type T, Type J) to your length specifications.
The PSC Biotech Professional Services Business Unit mission is to provide the outsourced services commonly needed by Life Science customers, including:Click to Read More
- Project Management, Automation, Facilities, Process Engineering, Reliability, Conceptual Design and GxP Design Reviews
- Clinical Services
- Clinical Trials Auditing, Clinical Trials Databases
- Commissioning and Validation
- MS Excel Spreadsheet Validation, Computerized System Validation, Network Qualification, Software Validation, Cleaning Validation, Process Validation, Shipping Validation, Cold Chain Qualification, Cold Chain Package Qualification, Analytical Method Validation, Equipment Qualification, Commissioning, ASTM E2500, Remediation, Gap Assessment
- GLP Audits, GCP Audits, GMP Audits, Gap Assessments, Remediation, 483 Responses, Warning Letter Responses, Consent Decree Support
- Project and Program Management
- We can provide support to PMO initiatives, with PMI/PMP certified professionals.
- Quality Assurance
- Risk Assessments, QA Oversight, QA Review & Approval, Quality Management Systems, Six Sigma Black Belt, Six Sigma Green Belt, Kaizen Events
- Regulatory Affairs
- IND, NDA, BLA, ANDA, Preapproval Inspections (PAI), IDE, 510K, PMA and FDA Registered Agent Services
- Technical Services
- Technical Transfer, Scale-up, Cleaning Validation, Process Validation, Analytical Method Validation, Process Development, Cold Chain Qualification
- GLP, GCP and GMP