Oxford delivers regulatory affairs consultants to clients who need them for compliance and validation projects, right now.

Coverage. Through our proprietary recruiting method, we've established a national network of senior regulatory affairs specialists, and direct contact with hundreds of front–line managers involved in regulatory compliance projects.

Expertise. Our regulatory compliance service offers experienced consultants to assist clients in the Pharmaceutical, Biotechnology, Medical Devices, and related Life Sciences industries with validation, auditing, system, and quality issues, and to achieve compliance with FDA, CE Marking, and ICH guidelines and regulations.  Specifics include:

• 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.

• Auditing.  Auditing to determine compliance with applicable regulations, guidelines, procedures, and policies for Part 11, quality systems, vendors, and IT compliance.

• Writing submissions, documentation, and remediation.  510k submissions, AER's, remediation/resolution management, technical papers and complaint handling.

• Compliance and Quality Management.  Development of complete quality systems, including compliant management, deviation management, CAPA, change control, training, and document management and control.  Methodology, policy, and procedure development.  Gap/risk assessment.

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

The latest edition of The Oxford Index for Compliance 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 regulatory compliance who can hit the ground running, come to Oxford.