Offering non-clinical expertise across a range of pharmaceutical and medical device sectors

Non-clinical development capabilities

20+ years experience within various pharmaceutical/CRO settings covering small molecular entities, vaccines, large molecules/biologicals and medical devices; 

Proficient in the design, preparation and implementation of in vivo and in vitro studies related to all non-clinical development activities;

Expertise across various therapeutic areas, including numerous modes of administration and various animal species;

Available services include:

• Single point of contact in monitoring and coordinating outsourced studies;
• Author non-clinical safety sections of Briefing Documents, Investigator Brochures (IB), Investigational New Drug (IND) and Clinical Trial (CTA) applications;
• Regulatory non-clinical queries.

Biocompatibility and toxicology risk assessment capabilities

Biological risk assessments, evaluation plans, gap analyses and reports, in compliance with ISO 10993-1, ISO 10993-17 and ISO 14971;

Design and preparation of in vivo and in vitro studies related to all biocompatibility development activities;

Evaluation of chemistry data following extractable and leachable testing;

Toxicological risk assessments and determination of appropriate margins of safety;

Proficient in the use of threshold levels (TTC) in association with ISO TS21726 and production of mitigations and derive contingencies for the presence of contaminants/impurities/extractables;

Can act as the single point of contact in monitoring and coordinating outsourced studies.