Clinical services & Regulatory support
At Propharmex, we extend our regulatory expertise into the clinical domain by providing end-to-end scientific and regulatory support for clinical studies, specifically tailored to meet Health Canada and Global requirements. Our team works closely with clients to ensure clinical documentation is scientifically robust, regulatory-compliant, and strategically positioned for approval.
Our Clinical Services Include:
- Protocol Development & Review
- Bioequivalence (BE) Study Design and Review
- Analytical & Bioanalytical Validation Review
- Scientific Consultation for Clinical Submissions
We provide strategic scientific guidance throughout the clinical phase, helping sponsors respond effectively to Global Health Authority queries during the review process. Our support includes crafting scientifically sound justifications, data explanations, and additional information requests, helping to accelerate the review timeline.
Whether you are preparing for initial clinical submissions or responding to submission queries, Propharmex is your trusted partner in navigating the complexities of clinical and regulatory integration.