Offering non-clinical expertise across a range of
pharmaceutical and medical device sectors
Pharmaceuticals / Biotechnology
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:
Medical Devices
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.
Contact us for more information regarding our services