Consultancy services 

DMPK consultancy goes beyond generating experimental data. It provides scientific interpretation, strategic planning and cross-program insight to support project decisions throughout discovery and development. 

An experienced DMPK consultant can help: 

• define the most relevant studies for the stage of development 
• interpret complex PK, ADME and metabolite data 
• identify liabilities early and recommend mitigation strategies 
• support human PK prediction and dose selection 
• contribute to regulatory documentation and agency interactions.

Expert DMPK data interpretation involves connecting findings across assays and study types to understand how a compound is likely to behave in humans. This includes evaluating exposure, clearance, bioavailability, metabolite burden, interaction risk and translational relevance. 

Clear interpretation matters for regulatory submissions because agencies expect not only data, but also a scientifically sound explanation of what the data means for safety, dose justification and clinical strategy.

Nuvisan uses a range of translational approaches to predict human pharmacokinetics from preclinical data, including: 

• in vitro–in vivo extrapolation (IVIVE) of metabolic clearance 
• allometric scaling from animal PK data 
• physiologically based pharmacokinetic (PBPK) modelling where appropriate 
• integration of plasma protein binding, blood-to-plasma ratio and metabolite data. 

The chosen approach depends on the compound type, available data and intended stage of development. 

Nuvisan’s DMPK consultants support regulatory submissions by: 

• preparing and reviewing DMPK sections for IND, IMPD and NDA/MAA submissions
• contributing to study reports and integrated summaries
• reviewing third-party reports for consistency and scientific accuracy
• supporting responses to health authority questions
• helping ensure that the DMPK package is presented clearly, consistently and in line with current regulatory expectations. 

A DMPK due diligence assessment is an independent review of a compound’s DMPK data package, typically performed during licensing, acquisition, investment or portfolio prioritisation activities. 

It can help assess: 

• the quality and completeness of the data package 
• whether the available data supports the intended clinical strategy 
• key risks related to exposure, metabolism, drug interactions or human translation 
• whether additional studies may be needed before the asset advances.

Yes. Nuvisan can provide embedded DMPK consultancy support for defined periods or specific projects. This can be useful where in-house resource is limited or where additional expertise is needed for program planning, interpretation, regulatory writing or cross-functional project support.