Email: enquiries@bioventurescl.com

Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Nonclinical programme

The expertise of BioVentures Consulting Limited is ideally placed to contribute to its clients nonclinical development programme

Conventional approaches for the nonclinical package may not be appropriate for biopharmaceuticals. The content of nonclinical package for biopharmaceutical product development is conducted on a case-by-case basis, which is driven by the scientific rationale. The expertise of BioVentures Consulting Limited is ideally placed to contribute to its clients nonclinical development programme, and has the experience and capability to project manage the whole nonclinical programme.

We have experience in designing, running and reporting nonclinical studies including single dose, repeat dose and chronic studies; and assess the need for genotoxicity, carcinogenicity and

reproductive toxicology for biopharmaceutical products (Note, for example, in vaccine development genotoxicity studies may be relevant). BioVentures Consulting Limited can compile the nonclinical sections of dossiers supporting new product development or regulatory submissions.

BioVentures Consulting Limited can also lead the nonclinical science debate and formulate rebuttals for product defences relating to issues such as host cell contamination concerns, safety concerns due to exaggerated pharmacology, species selection (e.g appropriate for testing human proteins in an animal system) and immunogenicity testing for neutralising and non-neutralising antibodies.

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