Clinical Support

ABS Labs have considerable experience in the conduct of clinical bioanalytical packages for inclusion in drug marketing authority applications (MAAs) submitted to regulatory and licensing bodies.

Specifically we offer:

Custom assay development and validation

 

Assay transfer

 

Support to first time in man studies (FTM) with agreed fast turnaround of data

 

Support to Phase I – IV including proof of concept (PoC) and bioequivalence studies.

 

Short time from study end to report

 

Non-compartmental PK analysis

 

Flexible reporting to meet the client’s specific requirements

 

 

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