Your Life Science Consulting

PSC Biotech™

Solutions Partner

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A Highly-Configurable Enterprise Quality Management System

Adaptive Compliance Engine® (ACE)

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MEDICAL DEVICE, BIOTECHNOLOGY, AND DIAGNOSTICS

EQUIPMENT RENTALS AND SALES

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Professional Services

We offer specialised professional consulting for the world’s most highly regulated industries. Learn why were the premier consulting firm for the life science industry.

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Our metrology unit is proud to be a distributor of validation equipment for use in the pharmaceutical, medical device, biotechnology, and diagnostics industries at a rental basis to fit the ever-changing needs of your company.

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PSC™ Services

Quality Assurance/Compliance

QA review (GLP, GMP, GCP), 483/Warning Letter Remediation, Risk Assessments, EM Program Analysis/Creation

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Audits

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Metrology/Calibration

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Commissioning Qualification Validation

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Technical Writing

Report writing, technical document writing expertise, FDA responses, SOP’s/Document/Forms, Safety Evaluations, Risk Mitigation

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IT/IS

IT Analysis, Configuration, Validation, Project Management System Integrations

Engineering

Conceptual, Staff Augmentation, Process, Facilities, Equipment Selection, etc.

Safety Evaluations on processes and LOTO development.

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Regulatory Affairs

ANDA / NDA Submissions to Regulator Bodies. Providing regulatory advice and practical assistance. FDA / EPA / OSHA / USDA / EU / etc.

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Project Management

Provide expert oversight of IT, Engineering, C&Q and Validation projects

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Our Offices Around The World

Singapore

26 Boon Lay Way, #01-92 Trade Hub 21, Singapore 609970

Phone: +65 65158081

Website

Madison, Wisconsin

Website

Dallas, Texas

Website

Pomona, CA (Headquarters)

700 Corporate Center Drive
Pomona, CA 91768

Website

St Louis, Missouri

20 S Sarah St
Saint Louis, MO 63108

Website

Shanghai

Unit A423, No. 1 Tongxin Rd
Hongkou District, Shanghai, 200083, China

Phone: +86 21 66287876

Taiwan

1F., No. 55, Wenshan Rd., Qionglin Township, Hsinchu County 307, Taiwan (R.O.C.)

Phone: +886 900776016

Ireland

PSC Biotech Ltd Unit 8, Block 8, Blanchardstown Corporate Park 1 Ballycoolin, Blanchardstown, Dublin 15, D15 N127 Ireland

Phone: + 353 1 9011707

United Kingdom

Lower Catherine Street, Newry, County Down, BT35 6BE

Phone: +44 203 475 8107

Netherlands

Switzerland

+41 445868156

Belguim

Pheonix, AR

Seattle, WA

Houston, TX

Austin, TX

Europe

Headquarters: PSC Biotech Ltd Unit 8, Block 8, Blanchardstown Corporate Park 1 Ballycoolin, Blanchardstown, Dublin 15, D15 N127 Ireland

Phone: + 353 1 9011707
Email: europehr@biotech.com

Other Locations: Germany, Switzerland, Spain, Italy, France, Poland, UK, N.Ireland, Netherlands

United States

Headquarters: 700 Corporate Center Dr. Pomona, CA 91768

Phone: +1 (909) 784-3350
Fax: +1 (909) 784-3354
Email: info@biotech.com

Other Locations: San Francisco, CA. Dallas, TX. St Louis, MO. Chicago, IL. Madison, WI. Washington, DC. Raleigh, NC. Pheonix, AR. Seattle, WA. Houston, TX. Austin, TX.

United Kingdom

Headquarters: PSC Biotech Ltd, Lower Catherine Street, Newry, Co Down, BT35-6BE, N. Ireland

Phone: +44 203 4758107
Email: europehr@biotech.com

Other Locations: Dublin, Switzerland, France, Germany, Spain, Italy, Netherlands, Poland, London, UK

Asia

Headquarters: 26 Boon Lay Way, Trade Hub 21 #01-92
Singapore 609970

Phone: +65 6515 8081

Other Locations: Singapore, Shanghai, Taiwan.