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Registrar Corp
144 Research Drive,
23666
Hampton, VA
USA
USA
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Contact
Devon McClellan
Director of Marketing
Beatrice Moreau
Senior Regulatory Advisor - Europe
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Our range of products
Product categories
- 07 Medical services and publications
- 07.10 Consulting services for health organisations
Consulting services for health organisations
Our products
Product category: Consulting services for health organisations
UDI and GUDID Compliance Solutions
Registrar Corp offers simple, low-cost solutions for FDA UDI and GUDID requirements, including:
- One-on-one guidance from a regulatory specialist
- Guidance on required data
- Submission-ready data for your device
- Submission of your UDIs to GUDID
- One-on-one guidance from a regulatory specialist
- Guidance on required data
- Submission-ready data for your device
- Submission of your UDIs to GUDID
Product category: Consulting services for health organisations
Electronic Medical Device Reporting (eMDR)
The U.S. Food and Drug Administration (FDA) now requires medical device manufacturers and importers to submit mandatory initial and supplemental adverse event reports in electronic format through FDA’s Electronic Submission Gateway (ESG). Registrar Corp can help submit your reports in eMDR format.
Product category: Consulting services for health organisations
Medical Device Master Files Submissions
Registrar Corp assists with Master File requirements. Our Regulatory Specialists can:
- File a new Drug Master File (DMF), Medical Device Master File (MAF), or Veterinary Master File (VMF)
- Update or Amend an MF
- Convert a paper DMF to eCTD
- File a new Drug Master File (DMF), Medical Device Master File (MAF), or Veterinary Master File (VMF)
- Update or Amend an MF
- Convert a paper DMF to eCTD
Product category: Consulting services for health organisations
FDA Compliance Monitor - Automate Supply Chain Risk Management
Easily identify vulnerabilities in your supply chain using the FDA Compliance Monitor.
With the FDA Compliance Monitor, medical device importers and manufacturers can monitor the following for their own company, their suppliers, and/or their competitors:
With the FDA Compliance Monitor, medical device importers and manufacturers can monitor the following for their own company, their suppliers, and/or their competitors:
- FDA Registration Number
- FDA Import Alerts
- FDA Import Refusals
- FDA Inspections
- FDA Warning Letters
- FDA Recalls
About us
Company portrait
Registrar Corp is a U.S. FDA consulting firm that helps companies in the medical device industry comply with FDA regulations. Registrar Corp offers assistance with FDA registration and listings, U.S. Agent, eMDRs, UDI submissions to the GUDID database, and more.
Since opening its headquarters in 2003, Registrar Corp has expanded to 20 international offices. Employees include former U.S. FDA officials, scientists, and industry experts.
Since opening its headquarters in 2003, Registrar Corp has expanded to 20 international offices. Employees include former U.S. FDA officials, scientists, and industry experts.
Company data
Number of employees
100-499
Foundation
2003
Area of business
Medical Services and Publications