- info@ddregpharma.com
- DELIVER BETTER DATA TO ENSURE FASTER APPROVAL
- USA
- India
- Germany
- Singapore
The Comprehensive Summary - Bioequivalence (CS-BE) is a key regulatory document required by Health Canada as part of the submission process for generic drugs. This document summarizes the conduct and analysis of pivotal comparative bioavailability (including bioequivalence) studies submitted in support of DIN Applications (DINAs), New Drug Submissions (NDSs) and their supplements, and Abbreviated New Drug Submissions (ANDSs) and their supplements that are filed with Health Canada. The CS-BE is central to the regulatory review, meaning that it significantly influences the decision-making process of Health Canada. A well-prepared CS-BE can determine whether the submission will be approved or require further information. It should provide a comprehensive, integrated summary of the overall content of information in the submission as it pertains to the comparability of the product with the Canadian reference product of proven safety and effectiveness under the proposed conditions of use. This should include a scientific rationale and justification for the study design used, the parameters assessed, and the standards applied.
In the context of the regulatory landscape, the CS-BE is crucial for:
With a deep understanding of bioequivalence studies and Health Canada’s specific requirements, our team ensures that each CS-BE is crafted with the highest level of precision and expertise. We provide expertise in preparing, reviewing, and ensuring the quality of data, ensuring that all necessary information is included to meet regulatory expectations. Our use of standardized regulatory templates streamlines the documentation process, guaranteeing that all necessary regulatory criteria are met efficiently. Additionally, we prioritize continuous training for our staff, staying updated on the latest regulatory guidelines and best practices, ensuring that every CS-BE aligns with current standards. These capabilities underscore DDReg’s strong proficiency in delivering high-quality bioequivalence documentation that meets rigorous regulatory expectations.