A’Nid Global Consultants have experience in a range of therapeutic areas geared towards research conducted within the United States. We assist both pharmaceutical and non-profit entities.
We will draft and coordinate submissions related to the following:
Institutional Review Board Submissions (IRB)
Expedited and Full Application Submissions
IRB Exemption
Amendments and Continuing Review
Informed Consent Forms
FDA New Drug Application (NDA/IND)
Meeting Package
Coordinate meetings between Sponsor & FDA
NDA documentation/application
Pre IND Meeting Request Letter