Your Life Science Consulting

PSC Biotech®

Solutions Partner

Quality Assurance/Compliance

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

Audits

Supplier, Gap Analysis, Lab Audit, Facility, PAI prep, GLP, GMP, Data Integrity.

Commissioning Qualification Validation

Potentially large, complex projects where clients outsource facility commissioning, new production suite commissioning, decommissioning, method validation, etc.

Technical Writing

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

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.

Regulatory Affairs

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

Project Management

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

Manufacturing Execution System (MES)

Custom solutions for automatically managing material inventory, product orders, and work protocols 

Metrology/Calibration

Equipment and instrument calibration services

Thermal mapping – Warehouse, Stability Chambers, etc.

Equipment Rental and Sales

Quality Assurance/Compliance

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

Audits

Supplier, Gap Analysis, Lab Audit, Facility, PAI prep, GLP, GMP, Data Integrity.

Commissioning Qualification Validation

Potentially large, complex projects where clients outsource facility commissioning, new production suite commissioning, decommissioning, method validation, etc.

Technical Writing

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

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.

Regulatory Affairs

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

Project Management

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

Manufacturing Execution System (MES)

Custom solutions for automatically managing material inventory, product orders, and work protocols 

Metrology/Calibration

Equipment and instrument calibration services

Thermal mapping – Warehouse, Stability Chambers, etc.

Equipment Rental and Sales

Our Services

Our services focus on refining your operations execution, limiting your organization’s risk, and expanding general productivity. As your life science solutions partner- our engineering, technical and consulting services incorporate all aspects of operation. 

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We’re Located Globally

+30 Countries Worldwide

United States

Office Locations (with Consultants): Pomona, CA. San Francisco, CA. Dallas, TX. St Louis, MO. Chicago, IL. Madison, WI. Washington, DC. Raleigh, NC. Phoenix, AZ. Seattle, WA. Houston, TX. Austin, TX. Denver, CO. Salt Lake City, UT. Orlando, FL.

Consultant Locations: Canada, Puerto Rico, Virginia, Wisconsin, Connecticut, Oregon, Mississippi, Maryland, Missouri, Indiana, South Carolina, Alabama, Georgia, New Mexico, Tennessee, Louisiana, Minnesota, Kentucky, New Jersey, Ohio, Indiana, Massachusetts, Michigan, Maryland.

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, Netherlands, Belgium
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, London

Asia

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

Phone: +65 6515 8081

Email: singapore_sales@biotech.com (Singapore) taiwan_sales@biotech.com (Taiwan)

Other Locations: Singapore, Shanghai, Taiwan, Japan, South Korea, Malaysia, Beijing

Middle East

Headquarters: Tel Aviv, Israel

Other Locations:Israel, Montenegro, India