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Regulatory Submissions
Multiple documents are examined by the regulatory authority prior to granting approval for clinical study or marketing. These documents are evidence that the product development was undertaken in compliance to regulatory guidelines that ensure the safety and quality of the formulation for sale in the specific marketing country.

For initial approval, sponsors are required to prepare huge multiple dossiers for regulatory submission which involves a lot of co-ordination with the participating sites. Once these initial study approval dossiers are submitted, the Indian regulatory authority (DCGI) gives their feedback in the form of Approved, Rejected or Additional Data Required.

To help sponsors get quick approvals Clinexa Life Sciences provides the following services:
    Pre Approval:
    Dossiers and Supplements

    Post Approval Requirements :
    Regulatory compliance documentation (variations & renewals)
    Regulatory submissions for extended drug development activities (abridged applications)
    Labelling & PI updates
    Pharmacovigilance and Periodic Safety Update Reports (PSURs)
    Annual reports & safety updates

In parallel to these regulatory submissions, EC submissions are carried out at various sites. With the help of experienced, full time clinical research coordinators we help the investigators with all the ethical committee submissions, documentation and safety reporting following strict timelines.
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