Services

By: Intellitext  09-12-2011
Keywords: Health Products, natural health, Natural Health Products

Assistance with Clinical Trial Applications (CTAs) to Health Canada NHP trials (phase I-III) in human subjects must be authorised by Health Canada's Natural Health Products Directorate (NHPD) before commencement of the trial. IWA assists companies with CTA submissions in a step-by-step process according to the following formula:1) Pre-application conference identifying & assessing the state of required documents and study endpoints
2) Development & editing of study documents (protocol,  informed consents, advertisements, ethical application, investigator brochures etc).
3) IWA development of CTA
4) Client review of CTA
5) Final review by IWA
6) Submission to NHPD/HCIf given the opportunity of early involvement, preferably already during the planning process of the clinical study, we guarantee that the documents will be submission-ready at the end of the predefined process.

Keywords: Health Products, natural health, Natural Health Products