Risk Assessment
In the pharmaceutical industry today, there are strict guidelines to adhere to throughout the product lifecycle. Some of them, like Risk Assessment, seem more complex and harder to adhere to than others. But maybe we just need a different perspective on what Risk Assessment is to inspire us to embrace it.
We offers a full suite of Risk Assessment services, including:
- Risk assessment of Excipients
- Risk assessment and scientific writeup for Impurity/Degradation/Leachable/Extractable
- Risk assessment for Elemental impurity as per ICHQ3D.
- Out of specification (OOS) justification
- BET report for Large Volume Parenteral (LVP).