Meet Ralph: Ralph is a project management consultant and subject matter expert in pharmaceutical cleanrooms, facility design, and regulatory compliance. He received a mechanical engineering degree from LeTourneau University. His industry career began at a major water...
INDUSTRY Medical Manufacturer SERVICES Quality Assurance Engineering Compliance Remediation Auditing SKILLS 21 CFR Part 820 and Subparts FDA Regulations Quality Management Systems Project Management The Challenge Our client needed to pass an impending FDA inspection....
INDUSTRY Laboratory Services SERVICES Clinical Research Organization (CRO) Drug Development RNA Biomarker Discovery SKILLS Biotech Lab QC RNA/DNA Extractions QPCR/PCR/RT-qPCR Medical Lab Experience The Challenge The Belgium government was seeking partners to aid in...
INDUSTRY Pharmaceuticals SERVICES Virtualization & Cloud Computing Migration Services SKILLS AWS • DynamoDB • RDS • EC2 Okta Javascript The Challenge Our client, a pharmaceutical organization specializing in drug delivery systems, was about to launch a...
Discover how Oxford’s team of medical writers completed 150 scientific validity reports within five months. INDUSTRY Medical Device SERVICES Regulatory Affairs SKILLS Medical Writing The Challenge With over 150 Scientific Validity Reports (SVRs) pending, an incredibly...
Discover how Oxford helped a pharmaceutical manufacturer open a fully validated facility within eleven months. INDUSTRY Pharmaceuticals SERVICES Commissioning & Qualification Validation Facility Set-Up & Inspection SKILLS Validation Plan Development The...
INDUSTRY Medical Device Manufacturing SERVICES FDA Compliance Manufacturing Equipment Identification and Installation SKILLS Business Analysts Functional Analysts Specification Development Project Management Commissioning and Qualification Validation The Challenge A...
INDUSTRY Biotechnology SERVICES Facility Expansion Validation Plan Development Commissioning & Qualification SKILLS Process Engineering Quality Engineering The Challenge As part of a facility expansion in Denmark, a global biotechnology manufacturer needed to...
Discover how Oxford promptly provided 15 consultants that were critical to achieving an observation-free site inspection. INDUSTRY Medical Device SERVICES Inspection Readiness Auditing & Assessment Documentation SKILLS FDA Compliance Quality Management Systems...
