Support Services —
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Throughout the product life cycle, our experts may assist you in overcoming challenges related to discovering the reasons of your difficulties or examining clinical and analytical data. Our experts, who have a strong foundation in science, are ready to help you with fieldwork or when liaising with regional health authorities.
Consulting
Consulting
To lower the risk involved with your next development steps, have experts assess the clinical and analytical data from a failed bioequivalency study, or ask for guidance on how to identify actions based on a GMP audit's results.
Training
Training
Whether your staff needs to learn more about IVIVC, Good Dissolution Practices, GMP, or in-vitro dissolution technique development, our expert training courses can be tailored to meet their needs.
Investigations
Investigations
Throughout the lifecycle of your products, our team helps you find potential root causes and put solutions in place for specific issues through troubleshooting and out-of-specification (OOS) investigations.
Q1/Q2 Regulatory Clearance
Q1/Q2 Regulatory Clearance
We have extensive expertise working with generic companies to help them demonstrate both qualitative and quantitative sameness to regulatory bodies in order to get a biowaiver.
Audits
Audits
Let us audit your manufacturing and testing contractors as an independent authority – or have certified subject matter experts perform technical audits of your analytical data to confirm compliance.
