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.
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