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...
Discover how Oxford’s consultants helped to remediate the issue and pass the FDA re-inspection. INDUSTRY Medical Device SERVICES Remediation Documentation Corrective & Preventative Action (CAPA) Quality Systems Improvement SKILLS FDA Compliance Quality Management...
Discover how Oxford provided assistance to keep the project on track. INDUSTRY Medical Device Manufacturing SERVICES Regulatory Affairs SKILLS EU MDR Compliance The Challenge When a European medical device manufacturer needed to achieve MDR compliance, they began the...
Discover how Oxford consultants revised a Quality Management System to meet FDA regulations within seven weeks. INDUSTRY Life Sciences SERVICES Quality Assurance Engineering Compliance Remediation Auditing SKILLS 21 CFR Part 820 & Subparts FDA Regulations Quality...
Discover how Oxford’s team helped create an FDA-compliant automated production process. INDUSTRY Medical Device SERVICES Automation Equipment Development Inspection Readiness SKILLS FDA Compliance Business Analysis Functional Analysis Specification Development Project...
