Reliable and Timely Batch Testing
Ensure timely turnarounds and clear communication with our lot release testing services. Our testing team has extensive experience performing cGMP batch release testing on a diverse range of drug products. Whether your product is a small molecule, biologic, nucleic acid-based therapeutic, or combination product, we have the knowledge and expertise to verify that it complies with your product specifications.
Our team excels in a diverse array of identification, assay, impurity, potency, in vitro, and physical property testing for all your drug product batch release needs. All your test results and raw data are also available 24/7 via our PacePort data portal, keeping you informed about the progress of your testing to meet your timelines.
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.