Our consultants have experience in obtaining regulatory approvals for new, ethical and generic pharmaceuticals from National Health Surveillance Agency (ANVISA – Brazilian FDA) Brazil. We offer a wide variety of Regulatory services. If you are in the process of developing a product and would like to file for approval in any of the above mentioned markets, we can assist you to help compile, review and file documentation. We may also be able to direct you to an experienced vendor who will be able to assist you to file your ANDA electronically.
We also can file suitability petitions on your behalf and obtain bioequivalence recommendations in a timely fashion.
We also can file suitability petitions on your behalf and obtain bioequivalence recommendations in a timely fashion.
}Regulatory Affairs Submissions – Research Study Phase III or IV.
}Compile Review and File CTD Anda’s.
}Coordinate With Regulatory Authority – File Amendments if Needed.
}Product Approval – Post Approval.
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