Life Sciences

Scientific Validity Reports

Scientific Validity Reports

Discover how Oxfordā€™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...

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Full Facility Validation in Eleven Months

Full Facility Validation in Eleven Months

Discover how Oxford helped a pharmaceutical manufacturer open a fully validated facility within eleven months.Ā  INDUSTRY Pharmaceuticals SERVICES Commissioning & Qualification Validation Facility Set-Up & Inspection SKILLS Validation Plan Development The...

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CQV for New Automated Manufacturing Equipment

CQV for New Automated Manufacturing Equipment

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...

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CQV for Biotechnology Facility Expansion

CQV for Biotechnology Facility Expansion

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...

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FDA Inspection Prep for Hearing Aid Maker

FDA Inspection Prep for Hearing Aid Maker

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...

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FDA Remediation for Cardiovascular Device Maker

FDA Remediation for Cardiovascular Device Maker

Discover how Oxfordā€™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...

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Gap Assessment and Workstreams for MDR Compliance

Gap Assessment and Workstreams for MDR Compliance

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...

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