PSC Biotech
PSC Biotech is a private life sciences consulting firm providing regulatory compliance, validation, auditing, and quality assurance services to pharmaceutical, biotechnology, and medical device companies across 52 countries, operating through consulting, software, and contract manufacturing divisions.
- Company typePrivate
- Founded1996
- HeadquartersPomona, United States
- Headcount251–500
- GTM typeB2B
- OfferingServices
What PSC Biotech does
PSC Biotech Corporation is a privately held life sciences consulting firm founded in 1996 and headquartered in Pomona, California. The company operates through three core divisions: PSC Biotech (professional consulting services), PSC Software (cloud-based enterprise quality management software), and BioTechnique (pharmaceutical contract manufacturing). It serves more than 1,000 life sciences clients across 52 countries, providing regulatory compliance, validation, auditing, quality assurance, technical writing, project management, engineering, and regulatory affairs services to pharmaceutical, biotechnology, and medical device manufacturers. Named customers include Illumina, Takeda, Johnson & Johnson Vision, and Texas Heart Institute.
The company's service portfolio spans the full lifecycle of life sciences compliance, from facility and equipment validation (Commissioning, Qualification, and Validation) to computer system validation and assurance (CSV/CSA), metrology/calibration, and 483/Warning letter remediation. Its PSC Software division offers configurable products including ACE (Adaptive Compliance Engine), ACE Essentials, and AuditUtopia for quality management and inspection tracking. PSC Biotech also distributes specialized equipment — including CLiMET particle counters and, through channel partnerships, De Lama sterilization solutions and Blue Ocean Robotics' UVD Robot Pharma autonomous UV-C disinfection systems. The company holds ANAB-accredited ISO 17025 certification for its metrology laboratory and employs former FDA auditors among its consulting staff.
PSC Biotech generates revenue through professional services engagements (project-based and retainer), software subscriptions (ACE, ACE Essentials, AuditUtopia), equipment rentals and sales, and pharmaceutical contract manufacturing through BioTechnique. It sells primarily through direct enterprise field sales with regional offices in North America, Europe, Asia Pacific, the Middle East, and Oceania, supplemented by exclusive distribution partnerships for complementary technology products. Pricing is quote-based and project-specific rather than tiered or publicly disclosed.
PSC Biotech firmographics
Firmographics- Name
- PSC Biotech
- Legal name
- PSC Biotech Corporation
- Website
- https://biotech.com
- Company type
- Private
- Founded year
- 1996
- Operating status
- Operating
- Headcount range
- 251–500 employees
- Short description
- PSC Biotech is a private life sciences consulting firm providing regulatory compliance, validation, auditing, and quality assurance services to pharmaceutical, biotechnology, and medical device companies across 52 countries, operating through consulting, software, and contract manufacturing divisions.
- Ownership category
- akta.pro rank
PSC Biotech industry classification
Industry- Product category
- Life Sciences Consulting and Compliance Services
- NAICS
- Management, Scientific, and Technical Consulting Services (5416), Software Publishers (513210)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Prepackaged Software (7372)
- akta.pro primary industry
- Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)
- akta.pro secondary industry
- Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11) (HLAGAKAG)
Keywords
Where PSC Biotech is headquartered
LocationHeadquarters
- HQ city
- Pomona
- HQ country
- United States
- HQ region
- North America
Offices9 records
Markets served
PSC Biotech business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- Professional Services Consulting: Life science consulting services including regulatory compliance, validation, auditing, quality assurance, technical writing, project management, engineering support, and regulatory affairs. Revenue generated through project-based engagements and retainer arrangements.
- Equipment Rentals and Sales: Rental and sales of validation equipment including CLiMET particle counters and air samplers, with calibration services and technical support.
- Software Solutions: Cloud-based enterprise quality management software (PSC Software division) including ACE, ACE Essentials, and AuditUtopia products for inspection management and compliance tracking.
- Pharmaceuticals Contract Manufacturing: Contract manufacturing services through BioTechnique division for pharmaceutical products.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom project-based pricing |
Go-to-market motion2 records
Distribution channels5 records
Marketing channels4 records
PSC Biotech product offering
Product offeringCore offering
PSC Biotech provides life sciences consulting services including commissioning, qualification, and validation (CQV), computer system validation (CSV/CSA), auditing, metrology/calibration, quality assurance/compliance, technical writing, project management, engineering, and regulatory affairs for pharmaceutical, biotechnology, and medical device companies. The PSC Software division sells cloud-based enterprise quality management software (ACE, ACE Essentials, AuditUtopia), and BioTechnique offers pharmaceutical contract manufacturing.
Product overview
PSC Biotech operates as a multi-divisional life sciences solutions provider consisting of three distinct divisions: PSC Biotech (professional consulting services), PSC Software (software products including ACE and AuditUtopia), and BioTechnique (pharmaceutical contract manufacturing). The consulting division offers a comprehensive portfolio of professional services including Commissioning, Qualification, and Validation (CQV), Computer System Validation/Computer Software Assurance (CSV/CSA), Auditing, Metrology/Calibration, Quality Assurance/Compliance, Technical Writing, Project Management, Engineering Support, and Regulatory Affairs. Additionally, the company distributes specialized equipment including CLiMET particle counters and air samplers, and partners with Blue Ocean Robotics (UVD Robot Pharma) and De Lama (sterilization solutions) to offer advanced contamination control and sterilization technologies. Services are delivered through strategically located global offices spanning North America, Europe, Asia, Australia, and the Middle East.
Differentiator
Problem solved
Functional benefit
Brands
- PSC Software: Cloud-based software solutions division offering ACE, ACE Essentials, and AuditUtopia products for enterprise quality management, inspection management, and compliance tracking.
- BioTechnique
- ACE
- ACE Essentials
- AuditUtopia
Products and services
- Commissioning, Qualification, and Validation (CQV) Professional consulting services for CQV of small- to large-scale engineering projects including facilities, utilities, equipment, laboratories, processes, cleaning, and manufacturing lines, delivered from Validation Master Plan through Summary Reports. Targeted at pharmaceutical, biotechnology, and medical device manufacturers.
- Computer System Validation / Computer Software Assurance (CSV/CSA) Validation services for enterprise applications, analytical equipment software, QMS, ERP, LIMS, MES, and clinical systems, including risk assessment, data integrity, and CSV/CSA policy and procedure development.
- Auditing Services Global auditing services including supplier audits, gap analysis, risk assessments, lab audits, PAI prep, GLP, GMP, data integrity, and CSV audits, leveraging PSC's global team.
- Metrology/Calibration Services ISO-certified equipment and instrument calibration services performed on-site or at PSC metrology laboratories, including thermal mapping for warehouses, stability chambers, freezers, and refrigerators.
- Quality Assurance/Compliance Full range of QA services for GxP environments including guidance, review, policy and procedure development, 483/Warning letter remediation, change control, risk management, deviations, CAPAs, quality agreements, and training.
- Technical Writing Technical documentation services including report writing, FDA response letters, policies, SOPs, documents, forms, protocols, methods, and specifications.
- Project Management Full-service project management from conception to implementation, covering scope, budget, scheduling, resources, and stakeholders, with expert oversight of IT, engineering, and CQV projects.
- Engineering Support Full engineering services from concept to implementation, including facility design and equipment selection for life sciences manufacturing operations.
- Regulatory Affairs Support for ANDA/NDA submissions and regulatory advice across FDA, EPA, OSHA, USDA, EU, and other international regulatory agencies.
- Equipment Rentals/Sales Rental and sales of validation and monitoring equipment including CLiMET particle counters and microbial air samplers used for cleanroom and controlled environment validation to meet ISO 14644 and EU GMP specifications.
- De Lama Sterilization Solutions De Lama S.p.A.'s advanced sterilization, washing, and decontamination solutions including the HyPerPure vH2O2 sterilizer, MagnetoDoor, and ZeroStop sterilization tunnel, offered to life sciences manufacturers through PSC Biotech's exclusive distribution arrangement.
- UVD Robot Pharma Autonomous UV-C disinfection system using 254nm UV-C light to eliminate up to 99.99999% of microorganisms, with full digital documentation for GMP cleanroom contamination control and Annex 1 compliance. Distributed in partnership with Blue Ocean Robotics.
- ACE (Adaptive Compliance Engine) Cloud-based, highly configurable workflow-based enterprise quality management system (EQMS) under the PSC Software division for GxP-regulated enterprises.
- ACE Essentials EQMS software for highly regulated industries with pre-built SOPs, offered under the PSC Software division.
- AuditUtopia Real-time inspection audit management system under the PSC Software division for hosting inspections and audits.
- BioTechnique Pharmaceutical Contract Manufacturing Pharmaceutical contract manufacturing services delivered through the BioTechnique division of PSC Biotech Corporation.
Quantifiable outcome
- 1000+ clients served globally
- +1 more outcomes
Companies that use PSC Biotech
Customer profileNamed customers4 records
Segments3 records
Ideal customer profiles3 records
PSC Biotech technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
PSC Biotech partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- De Lama S.p.A.corePSC Biotech appointed as exclusive distributor and local service provider for De Lama S.p.A.'s product portfolio across the life sciences industry in the United States, Canada, Singapore, and Australia. De Lama specializes in advanced sterilization, washing, and decontamination solutions including the HyPerPure® vH202 sterilizer, MagnetoDoor®, and ZeroStop® sterilization tunnel. The partnership combines PSC Biotech's expertise in pharmaceutical consulting, validation, and compliance with De Lama's advanced sterilization technologies.
- Blue Ocean RoboticscorePSC Biotech partnership with Blue Ocean Robotics to distribute the UVD Robot Pharma autonomous UV-C disinfection system across the United States, Australia, and Singapore. The partnership targets pharmaceutical manufacturers seeking to strengthen Annex 1 compliance and contamination control programs in GMP cleanroom environments. Combines Blue Ocean Robotics' automation and UV-C technology with PSC Biotech's GMP and regulatory expertise.
Scale indicators3 records
Recent moves6 records
Expansion highlights5 records
PSC Biotech competitors and assessment
Company assessmentDirect peers
- ProPharma Group: Mid-market pharma/biotech regulatory, compliance, validation and quality consulting firm - the closest direct peer to PSC Biotech's core consulting services. Both target emerging and mid-market manufacturers with GxP QA, auditing, CSV and regulatory affairs offerings.
- Veeva Systems: NYSE-listed life sciences software provider whose Vault QualityDocs, Vault QMS and Vault Validation products compete head-on with PSC Software's ACE and AuditUtopia. Direct EQMS competitor and the dominant scale player in life sciences SaaS.
- MasterControl: EQMS/QMS software provider purpose-built for regulated manufacturers, competing with PSC Software's ACE and ACE Essentials products. Overlaps closely on customer profile (mid-market life sciences manufacturers) and core feature set.
- Kneat Gx: Validation lifecycle management software (paperless validation) for regulated industries, directly comparable to PSC's CSV consulting and a complementary software product. Listed on TSX Venture under KSI.
Broad incumbents
- Parexel International: Large global CRO with established regulatory affairs, validation, and quality consulting services across the full life sciences value chain. Overlaps with PSC's consulting business at the upper end of the market.
- Charles River Laboratories: NYSE-listed life sciences services and contract manufacturing platform overlapping with PSC's regulatory/quality practice and BioTechnique contract manufacturing division. Operates globally across multiple regulated service lines.
- ICON plc: Global CRO with regulatory, medical affairs, and quality/validation consulting capabilities serving pharma and biotech. Comparable to PSC at the enterprise tier of the consulting market.
- IQVIA: NYSE-listed life sciences technology and services giant whose technology, regulatory, and quality practice overlap with PSC's consulting and software offerings. Largest scaled competitor in the regulated services market.
Emerging players
- Arriello: European-focused life sciences regulatory, compliance and CSV specialist with strong overlap to PSC Biotech's consulting services. Smaller in scale but a clear functional peer in the European mid-market.
- Dot Compliance: Israeli-based life sciences compliance/eQMS software company whose QMS, training and document management products compete with PSC Software's ACE and AuditUtopia. Direct competitor in the compliance-software niche.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
PSC Biotech social profiles
Digital presencePSC Biotech compliance and trust
Trust signalCompliance1 record
PSC Biotech financial estimates
Financial estimateRevenue estimate
Valuation estimate
PSC Biotech leadership team
Management profileNumber of profiles
Profiles8 records
PSC Biotech subsidiaries and ownership
Company hierarchySubsidiaries3 records
PSC Biotech funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
PSC Biotech M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about PSC Biotech
What does PSC Biotech do?
PSC Biotech provides life sciences consulting services including commissioning, qualification, and validation (CQV), computer system validation (CSV/CSA), auditing, metrology/calibration, quality assurance/compliance, technical writing, project management, engineering, and regulatory affairs for pharmaceutical, biotechnology, and medical device companies. The PSC Software division sells cloud-based enterprise quality management software (ACE, ACE Essentials, AuditUtopia), and BioTechnique offers pharmaceutical contract manufacturing.
Is PSC Biotech a public or private company?
PSC Biotech is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was PSC Biotech founded?
PSC Biotech was founded in 1996. It employs 251 to 500 people.
Where is PSC Biotech based?
PSC Biotech is headquartered in Pomona, United States, in the North America region.
How does PSC Biotech make money?
Four revenue lines are on record. Professional Services Consulting is the primary driver. The others are equipment Rentals and Sales, software Solutions and pharmaceuticals Contract Manufacturing.
Who are PSC Biotech's main competitors?
Direct peers on record are ProPharma Group, Veeva Systems, MasterControl and Kneat Gx. Broad incumbents are Parexel International, Charles River Laboratories, ICON plc and IQVIA. Emerging players are Arriello and Dot Compliance.
Does PSC Biotech have an API?
No public API is recorded for PSC Biotech.
What industry is PSC Biotech in?
PSC Biotech's product category is Life Sciences Consulting and Compliance Services. Its primary akta.pro industry code is HLAGAKAI, Clinical Quality Assurance (GCP QA, TMF/QMS oversight), with a secondary code of HLAGAKAG, Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11). Its NAICS code is 5416 and its SIC code is 8731.