Support Services —
Need help?
Request a QUOTE
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
Consulting
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.
Training
Training
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.
Investigations
Investigations
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.
Q1/Q2 Regulatory Clearance
Q1/Q2 Regulatory Clearance
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.
Audits
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.
