Support Services – Need help?

Support Services —
Need help?

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Whether you require help with identifying potential causes of your individual problems or need help with reviewing analytical and clinical data, our experts can help you to overcome the various chellenges throughout the product life cycle. Deeply rooted in scientific experience, our specialists are prepared to assist you in interactions with local health authorities - or with hands-on troubleshooting.

Consulting

De-risk your next development steps by having experts review analytical & clinical data from a failed bioequivalence study – or get guidance in defining actions based on the results of a GMP audit.

Have professionals evaluate the analytical and clinical data from a failed bioequivalence research to reduce the risk associated with your next development steps, or seek advice on how to define actions based on the findings of a GMP audit.

Training

Whether you would like to learn more about GMP, in-vitro dissolution method development, Good Dissolution Practices, or IVIVC, our professional training courses can be adapted to the specific needs of your team.

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

From troubleshooting to out-of-specification (OOS) investigations, our team assists in identifying possible root causes and implementing solutions for specific problems throughout the lifecycle of your products.

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

We are an experienced partner in guiding generic companies through the process of proving qualitative & quantitative sameness with regulatory authorities to obtain a biowaiver.

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

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.

What are you looking for?