regulatory and quality system professionals | 919.313.3960

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 by meeting FDA compliance requirements and international medical device, biotech and pharmaceutical regulations and standards.

FDA Compliance Consulting

Regulatory Affairs

Satisfy US FDA compliance and global authorization requirements

FDA Compliance Consulting - Quality Assurance

Quality Assurance

Achieve product quality standards and operational efficiency

FDA Compliance - Medical Device Quality Certification

Quality Certification

Meet quality standards to bring your product to market internationally

FDA Compliance - Quality Consulting

On-Call Quality Support

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

FDA Compliance - Medical Device Safety Testing

Safety Testing Management

Manage product quality and safety requirements for global and FDA compliance

FDA Compliance - Technology and Software Validation

Technology Management

Minimize risk with compliant business and product technologies

FDA Compliance - Regulatory Document Management

Data Integrity

Address the integrity of your data before it becomes an issue

FDA Compliance - Regulatory Business Processes

Business Operations

Ensure records, signatures and documentation are reliable