# PSC Biotech®

> PSC Biotech is a global life sciences services company combining engineering, validation, regulatory and quality consulting with PSC Software’s cloud quality systems and BioTechnique’s sterile injectable contract manufacturing. Its clients include emerging biotech companies and established pharmaceutical and medical device organizations.

- **Founded:** 1996
- **Headquarters:** Pomona, United States
- **Founders:** John Clapham (Founder, President and CEO)
- **Products:** CQV services, CSV and CSA services, Quality, regulatory and audit consulting, Metrology and equipment services, ACE
- **Notable:** Founded in 1996 and active for three decades by 2026., Reports operations in 52 countries and more than 1,000 clients served., Launched ACE Essentials in 2019 and ACE mobile app in 2022.

## Products & services

- **CQV services** — Commissioning, qualification and validation of facilities, utilities, equipment, processes, cleaning and analytical methods.
- **CSV and CSA services** — Validation and assurance support for computerized systems, including enterprise and laboratory applications.
- **Quality, regulatory and audit consulting** — Quality systems, remediation, audit readiness, regulatory submissions, technical writing and project management.
- **Metrology and equipment services** — Instrument calibration, thermal mapping and life science equipment rentals and sales.
- **ACE** — Cloud-based quality management platform with configurable workflows, document control, training, quality events and audit trails.
- **ACE Essentials** — Preconfigured eQMS offering launched for startups and regulated organizations; current packaging includes interconnected quality workflows.
- **AuditUtopia Powered by ACE** — Inspection request tracking and live scribe notes; ACE Inspection adds enterprise features.
- **ACE mobile app** — Mobile access to quality tasks, training, document review and signatures on iOS and Android.
- **BioTechnique** — Sterile injectable contract development and manufacturing, including cytotoxic and high-potency fill-finish and lyophilization.

## Achievements

- Founded in 1996 and active for three decades by 2026.
- Reports operations in 52 countries and more than 1,000 clients served.
- Launched ACE Essentials in 2019 and ACE mobile app in 2022.
- BioTechnique announced its York facility in 2021, with 163,885 square feet and 42,000 square feet of ISO 7/8 cleanrooms.
- Published a Thermo Fisher VVS case study describing migration from manual inspection tracking to AuditUtopia.

## Latest updates

- **2026-05** — Announced exclusive distribution and local service partnership with sterilization technology company De Lama.
- **2026-08** — Published guidance on data integrity governance across CDMO networks.
- **2026-09** — Published an article on electronic product information and regulatory content readiness.

## Links

- Website: https://biotech.com/
- LinkedIn: https://www.linkedin.com/company/psc-biotech-corp/
- Twitter/X: https://twitter.com/PSCBiotech
- YouTube: https://www.youtube.com/channel/UC41hclQoqytYsGFf0VFrsKA
- Instagram: https://www.instagram.com/pscbiotech/
- Facebook: https://www.facebook.com/PSCBiotechCorporation/

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Profile page: https://yespress.io/psc-biotech
Published by YesPress — https://yespress.io
Last updated: 2026-09-30