Regulators increasingly expect scientific justification and risk-based approaches to analytical testing and validation programmes. Over-testing increases cost and complexity, while under-testing risks non-compliance. Our scientific consulting services optimise analytical strategies, reduce unnecessary studies, and prepare risk–benefit documentation aligned with regulatory expectations. 

We help pharmaceutical and biotech companies balance efficiency, compliance, and inspection readiness.

Analytical strategy definition

Development of regulatory-aligned analytical strategies based on scientific risk assessment according to ICH Q9.

Study optimisation and reduction

Optimisation and reduction of testing programmes through risk-based justification.

Risk–benefit documentation for regulators

Preparation of structured scientific justification documents supporting regulatory dialogue.