Quality Control Analysis

Quality Control analyses are routinely performed at Solvias according to GMP quality standards for

  • Drug substances
  • Drug products
  • Intermediates
  • Starting materials
  • Excipients

Analytical methods can be transferred to or from the customer. Following ICH guidelines, GMP method transfer follows a formal process with transfer protocols and reports. Alternatively, the methods may have been developed and validated at Solvias previously, or they are simply compendial routine methods that are already in place at Solvias or requiring verification only.

Analytical Packages or Single Methods
Based on full cGMP compliance we can take over the entire Quality Control testing program of a product. In many cases, this option provides a cost-effective and trouble-free solution for our customer. You simply send us a sample of your product, and we deliver the results in a Certificate of Analysis or an analytical report that can be used to immediately release the product. Of course, Solvias is also pleased to perform selected methods of your monograph if this option is better suited to your needs.