We can advise on all aspects of the chemical analysis of pharmaceuticals and biopharmaceuticals. Examples of our remote review service has recently included the review of:
- Out of trend (OOT) and out of specification (OOS) investigations;
- Analytical methodology for analysis of nitrosamines by LC-MS/MS
- Method validation protocol
- Pharmacopoeia method verification protocol
- SOP on method validation
- Analytical method data for submission of a variation
If this service would be of interest then please contact us to find out how we can help.