Comprehensive experience in New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs) is rare, even among researchers who have successfully advanced development programs to late-stage clinical trials. The PROMETRIKA team includes statisticians, medical writers and other clinical research professionals whose combined experience has successfully developed more than 20 NDA/BLA/MAA dossiers for FDA and EMA regulatory submissions.
Our contributions include highly-specialized statistical analyses of integrated safety data, meta-analyses of efficacy data, and expert medical writing to support optimal strategies in positioning and presenting clinical research results in submission materials. Our marketing application work has been submitted to FDA, EMA and BfArM, and, on behalf of our clients, we have prepared and presented before FDA and advisory committees, including Oncologic Drugs Advisory Committee [ODAC].
The PROMETRIKA team has developed NDAs, BLAs, and MAAs in a variety of indications:
| INDICATIONS | ISS | ISE | Clinical Summaries |
|---|---|---|---|
| RARE DISEASES AND ONCOLOGY | |||
| Fabry Disease | - | - | |
| Focal Segmental Glomerulosclerosis and IgA Nephropathy [Berger’s Disease] | - | ||
| Pheochromocytoma and Paraganglioma | |||
| Acute Myeloid Leukemia [AML] / Acute Lymphocytic Leukemia [ALL] | |||
| Detection & Staging of High Risk, or Recurrent or Metastatic Prostate Cancer | |||
| HR+ Advanced Metastatic Breast Cancer | - | ||
| INFECTIOUS DISEASE | |||
| Complicated Urinary Tract Infection [cUTI] or Acute Pyelonephritis [AP] | - | ||
| NEUROSCIENCE | |||
| Multiple Sclerosis - 2 Compounds | - | ||
| Post-operative Pain Management | - | ||
| Post-partum Depression - 2 Compounds | - | ||
| Attention-Deficit / Hyperactivity Disorder [ADHD] - 2 Compounds | - | ||
| Schizophrenia | - | ||
| NEPHROLOGY | |||
| Chronic Kidney Disease [CKD] | |||
| Iron Deficiency Anemia in CKD | |||
| OPHTHALMOLOGY | |||
| Seasonal Allergic Conjunctivitis | |||
| PULMONOLOGY AND ALLERGY | |||
| Asthma | |||
| Seasonal Allergic Rhinitis | |||
| Multidose Dry Powder Inhaler [MDPI] Device Submission | - | - | |
* Summary of Safety and Effectiveness Data [814.44]