Email: enquiries@bioventurescl.com

Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Nonclinical: Toxicology & DMPK data requirements

BioVentures Consulting Limited has considerable experience in all nonclinical aspects of new product development. We understand the need for preclinical safety studies during drug development, and the requirements for ‘first-into-man' studies.

We understand the need to link animal data to the clinical setting

BioVentures Consulting Limited can advice, set-up, manage and report any aspect of the nonclinical programme, including the toxicology package of acute, sub-chronic, oncogenicity studies, and mutagenicity and reprotoxicology studies.

BioVentures Consulting Limited also provides advise on animal and human pharmacology and pharmacokinetics and the need to link animal data to the clinical setting.

BioVentures Consulting Limited understands the importance of nonclinical dose selection, formulations and routes of administration in these nonclinical assessments and in making the link between pharmacokinetics and pharmacodynamics.

The nonclinical aspects of a regulatory submission are presented in Module 4 of the Common Technical Document (CTD) and the nonclinical summary elements are presented in Module 2.4 as the Nonclinical Overview and in Module 2.6 as the Nonclinical written and tabular summaries. BioVentures Consulting Limited is able to compile these key summary documents and provide preclinical input into development of the Summary of product Characteristics (SmPC) at an early-stage.

For further information contact us on: This email address is being protected from spambots. You need JavaScript enabled to view it.

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