Let us guide you succesfully through your biomarker and PK assay activites 



FIRST STEP TOWARDS BIOANALYSIS EXCELLENCE

Strategic approach



Bioanalysis excellence starts from the top

A comprehensive and well-executed bioanalytical strategy pave the way

One of our core competences is working with bioanalysis on a strategic level


REMOVE LUCK FROM THE EQUATION

Plan the project 


Good scoping and planning of a bioanalysis project is easier said than done
A lot of small details can have significant impact on the outcome and efficiency
Having more than 100+ projects "under our belt", we know the pitfalls and the shortcuts


DO IT IN-HOUSE OR USE A CRO
Outsourcing


First evaluate if outsourcing is the right solution
If yes, then correct scoping of an outsourcing project
and choosing the right CRO make the difference between success or failure
With extensive experience from both pharma and CRO, we guide you towards success

NOT SURE IF ALL IS OK
Preventive auditing



Be better prepared for an EMA/FDA audit
We review and/or audit your bioanalysis SOPs and ways of working beforehand
Or let us audit a CRO with your QA before one of your critical projects are outsourced

SOPS MUST COMPLY WITH ICH M10

SOP assistance


A vast number of SOPs need to bereviewed and/or

rewritten in connection with the ICH M10 implementation

Let us help ensure your SOPs get fully compliant with the new guideline