NDA and EU Regulatory Submissions
Comprehensive experience in NDA and EU regulatory submissions is rare, even among researchers who have successfully advanced development programs to late-stage clinical research. The PROMETRIKA team includes several statisticians, medical writers and other clinical research professionals who have successfully developed dossiers for NDA and EU regulatory submissions. Our experience includes highly-specialized statistical analyses of integrated safety data, meta-analyses of efficacy data, and expert medical writing to support the optimal strategies in positioning and presenting clinical research results in submission materials. We also often participate in FDA meetings and calls both with and on behalf of our clients.
The PROMETRIKA team has coordinated NDA and EU regulatory submissions for sponsors in many therapeutic areas, including:
- ISS and ISE for a drug for the treatment of acute myelogenous leukemia.
- NDA, including ISS, ISE, Summary of Risk Benefit, Summary of Statistical Methodology and other summary sections for an oral asthma medication.
- Remedial services for a NDA for a post-operative pain management drug, including statistical analysis plans for ISS and ISE, preparation of numerous ad hoc analyses, and validation of the analysis datasets and tables for several CSRs as well as the ISS and the ISE.
- EMEA submission of an ISS for a rare genetic disease (orphan indication).
- An ISS for a rare genetic disease (orphan indication) submitted to FDA.
- NDA for a nasal steroid used to treat allergic rhinitis, including CSRs for 13 clinical studies, ISS, ISE, and the Statistical Methodology summary section.
- NDA for an ocular antihistamine to treat allergic conjunctivitis, including preparation of the ISS, ISE, Application Summary, pre-clinical sections, and individual study reports of 19 studies.
- European submission for a steroid metered-dose powder inhaler (MDPI), which was approved by the German regulatory body.