Auditing GAP Analysis And Compliance Services
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Service Location : All India
Service Mode : Online/Offline
Duration : Depends On Scope of Work
Type of Service Provider : Auditing GAP Analysis And Compliance Services
Regulatory assessment/Gap analysis of the supporting documents/data is critical for the registration of medicinal products. Though most of the Health Authorities (HAs) accept applications/dossiers in the CTD format, the level of content to be provided in the CTD section vary from each other. Thus, a thorough gap analysis/technical assessment of the documents/data enables the manufacturers to identify and mitigate the gaps before Regulatory submission. It will avoid Regulatory rejections of the submissions and minimize any major/critical queries to fasten the approvals.
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