Services

Our holistic approach applies Regulatory Affairs, Project Management, Quality and Compliance support to achieve a positive outcome for your product approvals and ongoing facility compliance.  Project management oversight supports the timely submission of original applications to the FDA, amendments during the review stage, ongoing monitoring of the review status of each pending submission and assistance with site readiness for FDA PAI/GMP inspections with the end goal of obtaining timely approvals.

U.S. Agent services are offered for foreign companies who wish to submit product filings and obtain facility approval to market products in the U.S. As your liaison to the FDA, we will work effectively with your firm to facilitate filings and information requests from the FDA to help avoid delays with product approvals.

To find out more about our services, please read below and click “read more” for additional information:

  • Regulatory Affairs: ATL Regulatory Consulting will support your firm with all Regulatory requirements. Read more…
  • U.S. Agent Services:  As your liaison to the FDA, we will work effectively with your firm to facilitate filings and information requests from the FDA to help avoid delays with product approvals. Read more…
  • Quality & Compliance: ATL offers a full range of Compliance and Quality services to help your firm maintain a GMP-compliant company profile. Read more…
  • Project Management: Our Project Managers will provide support and oversight on a wide variety of project management plans to help keep your firm in compliance and achieve your product filing goals. Read more…