Comprehensive Analytical Method Management
Leverage our comprehensive analytical method transfer, method validation, and maintenance services to support your drug products and medical devices. Analytical testing is a foundational activity throughout every phase of pharmaceutical and medical device development and commercialization. Our team provides reliable, responsive support for managing analytical methods throughout your product’s lifecycle. We offer guidance and services for analytical testing design, development, optimization, qualification, validation, transfer, and maintenance.
By partnering with our organization, your program relieves internal capacity, allows experts to refocus on alternative activities, transfers work when existing lab operations close, and gathers data supporting method reproducibility across our nationwide network of laboratories.
Secure Data Accessibility
Analytical methods, including both the Client Laboratory Methods (CLM) and Laboratory Methods (LM), are available for your access and review in PacePort. PacePort is our secure client data access portal and web-based data delivery system where you have access to methods, specifications, stability protocols, pull schedules, stability reports, final reports, sample receipt data, instrument raw data, and additional information at any time, from any location.
The copies are offered in high-resolution and in color, giving your team easy and clear viewing for review. Scanned images are of sufficient quality that they are often used during quality and regulatory (US FDA) audits. The information available via PacePort is thorough and complete, such that most, if not all, aspects of a data audit are available so your audit could be conducted remotely, guided by our Quality Assurance personnel.
Integrated Laboratory Services
When your team needs additional support, our scientists & professional services are ready. Our state-of-the-art facilities and highly trained experts add power to your project.