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Global Quality & FDA Compliance Consulting

Our services are designed to position your life science product and business operations for commercial success. We provide a complete spectrum of quality assurance, regulatory, technology and operational services to achieve commercialization success through compliance with US and international medical device, biotech and pharmaceutical regulations and standards.

Regulatory Affairs

Satisfy US FDA compliance and global authorization requirements

Quality Assurance

Achieve product quality standards and operational efficiency

Quality Certification

Meet quality standards to bring your product to market internationally

On-Call Quality Support

Reduce your business risks for noncompliance with quality support when you need it

Safety Testing Management

Manage product quality and safety requirements for global and FDA compliance

Technology Management

Minimize risk with compliant business and product technologies

Data Integrity

Address the integrity of your data before it becomes an issue

Business Operations

Ensure records, signatures and documentation are reliable