Regulatory Affairs

ATL Regulatory Consulting will support your firm with all Regulatory requirements. We will help your company develop sound regulatory strategy and be an active partner in ensuring submissions are correctly prepared and filed to the FDA in a timely manner. Using effective strategies and submission plans, we will provide regulatory support at every stage or alternatively, during specific segments of your projects.  We pride ourselves on our professional relationship with the FDA and will work tirelessly to guide your product through the approval process as expeditiously as possible. As part of the project management process, we follow up routinely with the FDA on each application discipline to ensure we always understand where the application is in the approval process and any review inquiries are addressed quickly.

  • Preparation, submission and management of regulatory filings to the FDA.  Assistance with addressing filing requirements from strategic advice on content to correct compilation of initial filings and post approval submission activities
  • Electronic CTD filing services
  • Review of FDA correspondence and submissions for completeness and compliance with FDA regulations and guidelines
  • Implementation of strategic submission plans and project management systems to strengthen FDA regulatory filings
  • Development of systems and procedures to support the control of regulatory submissions on a pre and post approval scale
  • Development of effective strategies to optimize approval times
  • Assistance with Field Alert reporting
  • Guidance, review and preparation of regulatory process and compliance SOPs in areas such as CTD development, field alerts, adverse event reporting, recalls and post approval filings
  • Assistance with the development and review of product labeling, electronic labeling filings, and drug listing activities
  • Regulatory due diligence audits as part of product or company acquisitions. We conduct effective regulatory assessments of approved products, applications pending approval, and evaluation of departmental regulatory control systems