Our services include the development, assessment and approval of protocols with the assistance of the New Zealand Health and Disability Ethics Committees. Our experience includes “first-in-human” (FIH) and ‘first-in patient”(FIP) studies, as well as generic bioequivalence studies. Zentech has completed over 500 parallel, fed and fasting, 2, 3 and 4 way bioequivalence studies, FIH, FIP, clinical and efficacy, safety, topical and dermatopharmacokinetics studies.
Furthermore, Zentech provides statistical consulting services to other organisations. This includes developing experimental designs and survey sampling plans, and also performing statistical analyses using various statistical programmes.
Zentech provides a full range of services including study design, protocol writing, ethics committee submission, assay development and sample analysis, trial co-ordination, management of the study and final reporting. Also, feasibility studies and safety studies, dissolution and stability testing, content and comparative bench chemistry bioanalytical method development and validation, biostudy sample analysis, certificate of analysis, comparative dissolution profile testing, essential similarity testing, stability testing, and moisture permeability testing are performed.
Our dedicated clinical site holds up to 60 participants at one time.
All analytical methods are fully validated according to FDA, EU and TGA guidelines prior to sample analysis.
Our analytical laboratory also provides pharmaceutical analyses ranging from active assays, dissolution, related substances, impurities, comparative dissolution profile testing, biowaivers based on the biopharmaceutics classification system (BCS), stability testing, essential similarity testing, and moisture permeability testing.