On-site labs with our own personnel offer greater control of samples and timelines, minimizing risk for our customers.
Full cGMP quality control analysis of clinical and commercial products is done by our in-house staff. With well-equipped, on-site analytical and microbiological laboratories as well as stability chambers, our scientists monitor end-to-end processes to confirm the safety and quality of each batch.
We implement a system-wide QbD approach to different phases of a clinical or drug product including raw materials, in-process, batch release, and stability / shelf-life evaluation.

Analytical Development

Testing Capabilities

ICH Stability Studies

We have extensive experience performing ICH-compliant stability studies for early-to-late stage drug product development programs over multiple years.

  • Deep understanding of regulatory requirements
  • Collaboration on study design
  • Rapid data turnaround
  • Strong data integrity   

Capabilities

On-site stability chambers