Biotech, Inc.
PSC Biotech® is a global life science consulting solutions provider with a mission to help companies in highly regulated industries achieve success through tailored services, innovative software, and contract manufacturing. With offices worldwide, PSC Biotech® offers expertise in regulatory compliance, validation, quality systems, and more, aiming to support the development and manufacturing of life-changing products.
Industries
Nr. of Employees
large (251-1000)
Biotech, Inc.
700 Corporate Center Drive, Pomona, CA 91768
Products
Cloud-based enterprise quality management system (turnkey eQMS)
Multi‑module cloud eQMS offering document control, training management, deviation/investigation and CAPA workflows, design control, risk management and reporting; offered as a configurable SaaS with API integration options and pre‑validated deployment practices to support regulatory requirements.
Inspection and audit lifecycle management software
Cloud software to manage inspections and audits, centralize requests and responses, coordinate inspection room and support teams, and provide metrics on inspection performance.
Turnkey eQMS package for early‑stage companies
Prepackaged electronic QMS including standard operating procedures and configured workflows to provide a compliant quality program rapidly for startups.
Cloud-based enterprise quality management system (turnkey eQMS)
Multi‑module cloud eQMS offering document control, training management, deviation/investigation and CAPA workflows, design control, risk management and reporting; offered as a configurable SaaS with API integration options and pre‑validated deployment practices to support regulatory requirements.
Inspection and audit lifecycle management software
Cloud software to manage inspections and audits, centralize requests and responses, coordinate inspection room and support teams, and provide metrics on inspection performance.
Turnkey eQMS package for early‑stage companies
Prepackaged electronic QMS including standard operating procedures and configured workflows to provide a compliant quality program rapidly for startups.
Services
CQV program delivery for facilities, utilities, equipment, laboratories and processes including validation planning, protocol execution and report generation.
Validation and computer software assurance for enterprise applications and laboratory/analytical instrument software, including risk assessments and data integrity reviews.
Global audit services including supplier audits, gap analyses, lab audits, PAI preparation, GLP/GMP and data integrity assessments.
ISO‑certified instrument calibration, on‑site service or laboratory calibrations, thermal mapping and equipment rental/sales.
QMS review and design, SOP/policy creation, remediation of regulatory observations, change control, risk management, deviations/CAPAs and training programs.
Preparation of technical reports, regulatory response letters, SOPs, protocols, methods and specification documents.
CQV program delivery for facilities, utilities, equipment, laboratories and processes including validation planning, protocol execution and report generation.
Validation and computer software assurance for enterprise applications and laboratory/analytical instrument software, including risk assessments and data integrity reviews.
Global audit services including supplier audits, gap analyses, lab audits, PAI preparation, GLP/GMP and data integrity assessments.
ISO‑certified instrument calibration, on‑site service or laboratory calibrations, thermal mapping and equipment rental/sales.
QMS review and design, SOP/policy creation, remediation of regulatory observations, change control, risk management, deviations/CAPAs and training programs.
Preparation of technical reports, regulatory response letters, SOPs, protocols, methods and specification documents.
Expertise Areas
- Regulatory compliance (FDA, EMA, other agencies)
- Quality management system implementation (eQMS design and deployment)
- Computerized system validation (CSV) and SDLC/GAMP5 compliance
- Commissioning, qualification and validation (CQV)
Key Technologies
- Cloud‑based multi‑tenant SaaS (eQMS)
- API integration between enterprise systems (QMS ↔ ERP/LIMS/MES/CRM)
- Inspection management software
- Document management systems
News & Updates
A California biotech firm, PSC Biotech, plans to create over 100 jobs and purchase a pharmaceutical manufacturing facility to produce cancer-fighting drugs, supported by a $1 million low-interest loan from the state.
PSC Biotech announced the acquisition of a high potency sterile injectable facility in Madison, Wisconsin, to expand its contract manufacturing services for sterile drugs.
PSC Software added API capabilities to their flagship product ACE™, enabling integration with other enterprise applications for life science companies.
PSC Software launched a new website showcasing their enterprise quality management and audit management software solutions for regulated industries.
PSC Biotech discusses updates to ISO standards and EU GMP Annex 1, and how companies can develop compliant environmental monitoring programs with PSC's help.
PSC Biotech shares insights on how to meet ISO 13485 and 21 CFR 820 standards, including improving procedures and compliance for medical device and diagnostic labs.
A California biotech firm, PSC Biotech, plans to create over 100 jobs and purchase a pharmaceutical manufacturing facility to produce cancer-fighting drugs, supported by a $1 million low-interest loan from the state.
PSC Biotech announced the acquisition of a high potency sterile injectable facility in Madison, Wisconsin, to expand its contract manufacturing services for sterile drugs.
PSC Software added API capabilities to their flagship product ACE™, enabling integration with other enterprise applications for life science companies.
PSC Software launched a new website showcasing their enterprise quality management and audit management software solutions for regulated industries.
PSC Biotech discusses updates to ISO standards and EU GMP Annex 1, and how companies can develop compliant environmental monitoring programs with PSC's help.
PSC Biotech shares insights on how to meet ISO 13485 and 21 CFR 820 standards, including improving procedures and compliance for medical device and diagnostic labs.