Qualifying Thirty Party
CRO
Technical Data Analysis
The analysis and presentation of bioequivalence study is as important as the bioequivalence study conduct itself. Deep assessment of the documents before submitting to the regulatory authorities provides us a complete roadmap for a successful submission with minimum possibility of queries being raised. CROs are able to conduct the biostudy however, in India there is no such CROwhich can perform data review and interpret the results of failed bioequivalence study comparing formulation aspects, dissolution profile and executed study and guide the sponsor for further strategy When bioequivalence studies fail to show therapeutic equivalence of the test drug compared to reference drug, it does not necessarily mean that the drugs are non-equivalent or that the study results cannot be used for future biostudy planning. Detailed investigation of failed biostudy is very crucial in strategizing future course of action. Utmost care is to be taken during review and compilation as it plays a direct role in obtaining regulatory approvals and achieving earliest possible availability of medicines in the generic market which in turn translates into businessfor the company. With years of experience in supporting generic bioequivalence submissions for international regulators such as USFDA, MHRA, EMEA, TGA, Health Canada & other regulated agencies, Pharmadesk has developed an unmatched skillset of reviewing the data. A dedicated quality assurance team at Pharmadesk focuses on review of clinical study reports, integrated study reports, method validation reports, eCTD formats and other relevant study data.
The bioequivalence study report is an important document which is submitted for review to regulatory agencies for approval to market their medicines. Every human being is prone to make mistakes; hence it is important to re-check the information in the dossier before filing it with regulatory agencies. It is also important that a dossier meant to be filed with a regulatory agency should be cross verified by a person other than the one who has complied the dossier. Through final review we provide the sponsor with the thoroughly reviewed bioequivalence study dossier along with all the related information as per the global regulatory standards and practices. With through knowledge of various regulatory guidelines our expert quality assurance team is able to provide full proof zero error data for ANDA and EU submissions to our clients. With an in–house team specialized for review, analysis and reporting, we are well placed to cater to most of the regulatory agencies.
Failure of bioequivalence study is beyond the scope of CRO and is a big loss to the sponsor financially as well as it delays the timelines. We at Pharmadesk with experience team of formulators, formulation analytical development and pharmacologist will perform the following tasks for you:
Pharmadesk quality assurance shall review the individual subject data for its completeness to rule out any data integrity issues which includes the following:
Pharmadesk quality assurance and medical writing team shall review the study reports and assures that it is in consistent with generated study raw data and in compliance with ICH E3 guideline for "Structure and Content of Clinical Study Report" which includes the following:
Pharmadesk regulatory affairs and medical writing team review shall the dossier and ensures that it is in compliance with required regulatory requirements and shall verify the following:
How to investigate a failed biostudy to find out the route cause of its failure?
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