Dr. Parisian was a former Chief Medical Officer at FDA and Lt. Commander in the United States Public Health Service. She is Board Certified in Anatomic and Clinical Pathology and a graduate of University of South Florida Medical School. She has had patient care experience in general practitice medicine, emergency medicine, occupational and public health medicine, and forensic medicine. While at FDA, she was publicly acknowledged through various awards as a "team player" well-versed in regulatory science".
As a guest lecturer, both inside and out of FDA, Dr. Parisian has been well received. She has an abilty to "successfully" translate FDA's regulatory requirements into understandable information.
MD Assist, Inc.'s expertise has been able to span all aspects of Food and Drug Administration (FDA) and has included:
|Clinical Trial Design||510K, ANDA|
|Investigational Product Exemption (IDE, IND)||Postmarket Study & Tracking|
|Pre-Market Approval (PMA, NDA, PDP, Licensing)||Mandatory Product Reporting|
|Health Risk & Adverse Event Evaluation||Good Manufacturing Practices (GMP)& QSR|
|Labels & Labeling||Product Promotion & Advertising|
|Patient & Investigator Communication||Data Review|
|Product Evaluation||Sponsor & Product Compliance|
|Product Complaints & Recalls||Alternative Medicine|
|Importing & Exporting||Biocompatibility|
|Education||Notification & Safety Alerts|
|Insititutional Review Board (IRB)||Informed Consent & Subject Rights|
|Orphan & Humanitarian Use Products||Combination Products|
The first MDA office was located in the scenic blue ridge mountains of Front Royal, Virginia. Beginning 2004, MDA opened a new office in sunny Phoenix, Arizona.