Regulatory
Elashoff Consulting provides regulatory services for the biotech/pharma industry, focusing on advisory committee preparation, genomics data submissions, and NDA review.
Advisory Committee Preparation
Advisory committee meetings are higly visible and critically important in the FDA review process. We have extensive experience presenting at and sitting on advisory committees. The following table lists recent advisory committees where we participated.
| Committee | Year | Topic | Who | Role |
|---|---|---|---|---|
| Transplant | 1998 | Cellcept | ME | presenter |
| Antiviral | 1996 | Bravavir | ME | presenter |
| Antiviral | 1998 | HIV Surrogate Markers | ME | presenter |
| Antiviral | 1999 | Abacavir | ME | presenter |
| Antiviral | 1999 | Relenza | ME | presenter |
| Anti-Infective | 2003 | Ranking Anti-Microbials | JE | member |
| Analgesics | 2001 | Celebrex | JE | member |
| Non-Prescription | 2000 | PPA | JE | member |
| Endocrine Metabolism | 2000 | Mevacor | JE | consultant |
| Arthritis | 2005 | COX-2 Inhibitors | JE | FDA voting consultant |
| Pulmonary | 1996 | Allegra | BE | presenter |
| Pulmonary | 1998 | Asthma Drugs | BE | presenter |
Genomics Data Submission
With a background in both regulatory issues and genomics, Elashoff Consulting can provide guidance on your submission of genomic data to the FDA. Michael Elashoff has worked with the FDA to help them set standards for genomic data submissions.
NDA Review
Having an outside review of your analysis/study reports prior to FDA submission can often be invaluable. With two former FDA reviewers, we can provide the reviewer perspective on your clinical submissions.
Legal
We have provided legal consulting on biostatistical and regulatory issues. Please contact us for more details.
