Scientific Review

An Integrated View
with Regulatory Insight

PharmaKinetic use our understanding of the drug development process to provide an integrated view of presented DMPK and clinical pharmacology data.

This expertise has been applied to submission documents and Scientific Advice meetings with regulatory agencies such as the FDA, MHRA and EMA.

Strengthening your Scientific Case

We are able to use our knowhow to assist the following activities:

Regulatory Collaboration

Expertise applied to; Scientific Advice meetings, regulatory documents (IND, NDA, CTA), and responses to questions raised following submission

Due Diligence

Due diligence activities related to the clinical pharmacology and DMPK aspects of potential drug candidates

Expert Testimony

Expert witness to support challenges to a patent position

Conference Support

Preparation of PK abstracts and posters for presentation at scientific meetings

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Unlock your drug’s potential with our pharmacokinetic expertise

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