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 |
REGULATORY AGENCY MEETING ATTENDANCE |
|---|---|---|---|---|
| RARE DISEASES AND ONCOLOGY | ||||
| Fabry Disease |
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|
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| IgA Nephropathy [Berger's Disease] – SubPart H Submission |
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| IgA Nephropathy [Berger's Disease] – Full NDA Submission |
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|
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| Focal Segmental Glomerulosclerosis |
-
|
-
|
||
| Pheochromocytoma and Paraganglioma |
-
|
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| Acute Myeloid Leukemia [AML] / Acute Lymphocytic Leukemia [ALL] | ||||
| Detection & Staging of High Risk, or Recurrent or Metastatic Prostate Cancer |
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|
|||
| HR+ Advanced Metastatic Breast Cancer |
-
|
-
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| INFECTIOUS DISEASE | ||||
| Complicated Urinary Tract Infection [cUTI] or Acute Pyelonephritis [AP] |
-
|
-
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| NEUROSCIENCE | ||||
| Multiple Sclerosis – Compound A |
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|
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|
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| Multiple Sclerosis – Compound B |
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|
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|
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|
|
| Post-operative Pain Management |
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|
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| Post-partum Depression - Compound A |
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|
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| Post-partum Depression - Compound B |
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|
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| Major Depressive Disorder |
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|
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| Attention-Deficit / Hyperactivity Disorder [ADHD] |
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|
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| Schizophrenia |
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| NEPHROLOGY | ||||
| Chronic Kidney Disease [CKD] |
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|
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| Iron Deficiency Anemia in CKD – FDA Submission | ||||
| Iron Deficiency Anemia in CKD – EMA Submission |
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| OPHTHALMOLOGY | ||||
| Seasonal Allergic Conjunctivitis | ||||
| PULMONOLOGY AND ALLERGY | ||||
| Asthma | ||||
| Seasonal Allergic Rhinitis | ||||
| Multidose Dry Powder Inhaler [MDPI] Device Submission |
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|
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|
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| HEMATOLOGY | ||||
| Reversal of Anti-Platelet Effects of an Anti-Coagulant |
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|
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* NDA-enabling specialized complex efficacy analysis on pivotal study
RARE DISEASES AND ONCOLOGY
Fabry Disease
IgA Nephropathy [Berger's Disease] – SubPart H Submission
IgA Nephropathy [Berger's Disease] – Full NDA Submission
Focal Segmental Glomerulosclerosis
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 – Compound A
Multiple Sclerosis – Compound B
Post-operative Pain Management
Post-partum Depression - Compound A
Post-partum Depression - Compound B
Major Depressive Disorder
Attention-Deficit / Hyperactivity Disorder [ADHD]
Schizophrenia
NEPHROLOGY
Chronic Kidney Disease [CKD]
Iron Deficiency Anemia in CKD – FDA Submission
Iron Deficiency Anemia in CKD – EMA Submission
OPHTHALMOLOGY
Seasonal Allergic Conjunctivitis
PULMONOLOGY AND ALLERGY
Asthma
Seasonal Allergic Rhinitis
Multidose Dry Powder Inhaler [MDPI] Device Submission
HEMATOLOGY
Reversal of Anti-Platelet Effects of an Anti-Coagulant
* NDA-enabling specialized complex efficacy analysis on pivotal study