Compliance is Built in, Not Bolted On

Compliance Fluent Professionals designing, implementing, deploying, and supporting modern products and systems that are audit ready and highly adaptable to scale with organizations.

Key Insights on CSA Adoption and Regulatory Expectations

Event Recap

OXG Partners with Global Medical Technology Company on Quality Management System Harmonization

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Building the Technical Team Behind Clinical Trial and Production Readiness

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Areas of Expertise

  • •Manufacturing

    •Quality

    •Validation

    •Product Development

    •Packaging

  • •Quality Assurance, Quality Control & Quality Systems

    •Quality Remediation, Gap Assessment & Quality Investigations

    •Risk Management

    •Post-Market Surveillance

    •Design Control

    •Process Development & Engineering

    •Compliance Engineering

    •Internal & External Audit

  • •Regulatory Submissions, Technical Writing & Regulatory Strategy Development

    •PMAs, 510(k)s, NDAs, ANDAs, BLAs, INDs, IDEs, etc

    •International Regulatory Filings, Product Registrations & Labeling

  • •Validation Engineering, Documentation Development, & Execution

    •Facilities, Utilities, Equipment, Process, Automation, test Method, Analytical method, Laboratory, Computer Systems, Software, & IT Validation

    •Cleaning & Sterilization; Packaging & Labeling

  • •Manager

    •Director

    •Vice President

    •C-Suite