Oxford delivers seasoned consultants to clients who need them for validation projects, right now.

Coverage. Through our proprietary recruiting method, we've established a national network of 1,200 senior quality, validation, and compliance experts, maintain direct contact with nearly 1,600 front-line managers involved in these projects, and engaged over 100 consultants on quality, validation or compliance-related assignments in the past year.

Expertise. Oxford offers experienced consultants to assist clients in the pharmaceutical, biotechnology, medical device, and related life science industries with quality, validation, compliance, auditing, and system issues, and to achieve compliance with FDA, CE Marking, and ICH guidelines and regulations. Our consulting expertise includes:

• Quality Assurance & Quality Engineering. Development of complete quality systems, including complaint management, deviation management, CAPA, change control, training, and document management and control. Methodology, policy, and procedure development. Gap/Risk assessment. Recalls, MDR’s and complaint handling. Auditing to determine compliance with applicable regulations, guidelines, procedures, and policies for Part 11, quality systems, vendors, and IT compliance.

• Regulatory Affairs. Writing submissions, documentation, and remediation including 510k submissions, AER's, PMA’s, IDE, remediation/resolution management, technical papers and complaint handling.

• Validation. Developing Standard Operating Procedures (SOP), Validation Support Processes (VSP), validation protocols (IQ, OQ, PQ), and validation master plans. Conducting validation executions and writing validation reports. Computer systems, software, process, cleaning, methods, facilities and utilities, equipment, IT infrastructure, and 21 CFR Part 11.

Results. We deliver results: Oxford fills the majority of quality, validation and compliance assignments for which we compete, and engaged over 30 consultants on related assignments in the past year.

The latest edition of The Oxford Index for Quality Assurance, Regulatory Affairs & Validation is available now.  View the summary results or register to receive the full report.

If you're looking for a consultant with a solid track record in validation who can hit the ground running, please email us or call the Oxford office nearest you.