PSC Biotech
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Regulatory, Tech Transfer & Support Services
Analytical & Bioanalytical Services
Manufacturing & Lab Equipment
Drug Product
Drug Substance
Consultants & Advisory Services
Company Overview
About
PSC Biotech is a global life science consulting solutions company established in 1996, providing compliance, engineering, validation, and quality services to pharmaceutical and biotech companies. The company offers commissioning/qualification/validation (CQV), computer system validation (CSV), quality assurance, regulatory affairs, auditing, metrology/calibration, and technical writing services. PSC Biotech previously operated an aseptic fill-finish manufacturing facility in Madison, Wisconsin, which was sold to LSNE (Lyophilization Services of New England). The company's subsidiary BioTechnique offers CDMO services separately.
Key Expertise
pharmaceutical consulting and compliance, CQV services, computer system validation, quality assurance, regulatory affairs, supplier qualification and auditing
Quick Facts
HQ:United States
Founded:1996
Consulting Services
PSC Biotech — Regulatory & Quality, Support functions
Quality, Regulatory & Compliance
Expertise
Quality and Supply Chain
Recruitment & Talent Services
Regulatory Compliance & GxP Systems (GMP/GDP/GCP/GLP )
Quality Management System implementation
Audit Readiness & Regulatory Inspection Support
Training & Talent Development (GxP, Technical, Regulatory, Lead
- Industry experience
- 30 years
- Engagement types
- consulting
Capabilities & Services
Markets Served
North America
Manufacturing Facilities
1 site worldwide
PSC Biotech - United States Facility
United States
Site Capabilities
3 capabilitiesSolid Dose Manufacturing
Oral Liquids
Topicals