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Website Snapshot of XFDA, LLC

XFDA, LLC

(240) 505-4396

9611 Potomac Dr, Fort Washington, Maryland   207446934 , USA

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Products & Services:

  • Fda Consultants
  • Fda Submissions
  • Submission Consultants

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profiles and submissions for review and endorsement by the authorities such as FDA and other International Regulatory Authorities. Regulatory Submissions xFDA Consultants provide... our clients direction through the entire regulatory submission process. Our consultants were Experts at the FDA and many have industrial experience. They have an excellent background... Devices and IVD Submissions Pre-Market Notification (510(k)) Pre-IDE Investigational Device Exemption (IDE) Pre-Market Approval (PMA) Pharmaceuticals and Biologics Submissions Pre...
in both. Sixteen years with the FDA as a reviewer of NDAs and other submissions. Eighteen years in the pharmaceutical Industry developing analytical methods, setting specifications... Protect Plus Global Contact Us CHEMISTS Expert holds a PhD in organic chemistry and minors in biochemistry and microbiology. Nineteen years at the FDA. Fourteen years as senior... scientist in the pharmaceutical industry. Chemistry reviewer of neuropharmacological Drug Products while at the FDA. Chair of Taskforce on two FDA guidelines and ICH expert on quality...
FDA submission consultants Home About Us Team Services Clinical Quality Systems Regulatory Training Solutions Compliance Expert Witness Consultants Medical Officers Chemists..., audits and label reviews. xFDA offers FDA - GMP, GCP and GLP inspections. DRUG DEVELOPMENT/SUBMISSIONS Our FDA consultants listen to clients' needs and plan a drug development program... specific for that firm's project. Our experts can draft regulatory submissions for firms or can review their regulatory submissions before submitting to the FDA. GENERIC DRUG...
Patent Protect Plus Global Contact Us MEDICAL DEVICE EXPERTS Expert previously worked at FDA Center for Devices and Radiological Health (CDRH) in its Office of Device Evaluation... for 8 years as a reviewer of 510k, PMA and IDE applications for cardiac medical devices (Rockville, MD). He reviewed all aspects of some of these submissions but the areas of his...) in the Office of In-Vitro Diagnostic Devices. In addition, he has extensive experience in radiation oncology. At the FDA, lead or was a member of teams of engineers, medical officers...
. BA - Business Administration - Brooklyn College, Brooklyn, NY Marilyn A. Apfel, PhD Dr. Apfel is a former FDA CMC expert and is an expert in FDA regulatory submissions. She... of applications for FDA submission. She advises on analytical issues, impurities, clinical supplies and packaging issues, drug substance and drug product stability issues, and all facets... and rolling submission. Prior to joining Mylan, Dr. Sherry served as a Medical Reviewer in the Division of Neuropharmacologic Drug Products at the Food and Drug Administration (FDA...

Company Profile:

Contact: 240-505-4396
Address: 9611 Potomac Dr
Fort Washington, Maryland   207446934 , USA
Url: http://www.xfda.com
Fax: 301-495-2721
   
Annual Sales: Below US$1 Million
Ownership: Woman owned
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