L. Reed Global QA
L. Reed Global QA, Inc. specializes in quality assurance GxP services for the biopharmaceutical industry, including development of GXP quality systems, vendor management, and clinical trial support. Led by Lisa Reed, the company has over 25 years of experience ensuring GxP compliance across biologics, gene therapy, and pharmaceutical sectors, with a focus on creating robust, audit-ready, and regulatory-compliant drug product packages.
Industries
Nr. of Employees
small (1-50)
L. Reed Global QA
Billerica, Massachusetts, United States, North America
Products
GXP QA/QC Consulting and Compliance Services
Comprehensive quality assurance and quality control consulting services delivering audit-ready systems across GLP, GMP, and GCP clinical phases to commercialization.
GXP QA/QC Consulting and Compliance Services
Comprehensive quality assurance and quality control consulting services delivering audit-ready systems across GLP, GMP, and GCP clinical phases to commercialization.
Services
Consulting to design and implement GLP/GMP/GCP quality systems aligned with FDA, EMA and ICH guidance to create audit‑ready documentation and processes.
Oversight of contract manufacturer activities including batch record control, investigations, deviations, change control and product disposition.
Develop and execute vendor qualification programs including questionnaires, on-site and for-cause audits, and quality agreement reviews to support supplier readiness.
Coordination of Quality Person activities and product staging to enable release into the EU for clinical trials, including EU declaration support.
Management of analytical testing programs including method development, validation and specification setting to support release decisions.
Support or oversight of cleaning validation, changeover qualification, equipment qualification and computer system/software validation activities.
Consulting to design and implement GLP/GMP/GCP quality systems aligned with FDA, EMA and ICH guidance to create audit‑ready documentation and processes.
Oversight of contract manufacturer activities including batch record control, investigations, deviations, change control and product disposition.
Develop and execute vendor qualification programs including questionnaires, on-site and for-cause audits, and quality agreement reviews to support supplier readiness.
Coordination of Quality Person activities and product staging to enable release into the EU for clinical trials, including EU declaration support.
Management of analytical testing programs including method development, validation and specification setting to support release decisions.
Support or oversight of cleaning validation, changeover qualification, equipment qualification and computer system/software validation activities.
Expertise Areas
- GxP quality systems development
- Clinical trial supply and GCP compliance
- CMC and manufacturing QA
- CMO oversight and qualification
Key Technologies
- Electronic document management systems and e-signatures
- Analytical method validation
- Stability testing protocols
- Serialization / track-and-trace systems