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...
Discover how Oxford’s team of experts completed product-specific and State-of-the-Art Literature Searches within four months. INDUSTRY Medical Device Pharmaceutical Consumer Products SERVICES Medical Writing SKILLS Clinical Evaluation Reporting The Challenge A...
Discover how the right Oxford consultants were able to provide support for a Data Integrity Remediation project when a client needed niche expertise. INDUSTRY Pharmaceutical SERVICES Remediation SKILLS ISO Compliance The Challenge A global pharmaceutical manufacturer...
