Services: Regulatory Submissions

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Since our founding in 1988, our staff has assisted in the preparation of numerous investigational new drug applications (INDs), drug and biologic marketing applications (i.e., NDAs and BLAs), and device applications in a variety of indications and therapeutic fields, to regulatory authorities in the United States, Canada, and Europe. The complexity of these applications has ranged from straight forward submissions to submissions requiring translation and integration of data from multiple international studies.

Examples of Submission Experience

  • Abbreviated New Drug Applications (ANDAs)
  • Biologic License Applications (BLAs), Amendments, and Supplements
  • Clinical Trial Applications (CTAs )
  • Clinical Trial Exemptions (CTXs)
  • Division of Drug Marketing, Advertising, and Communications (DDMAC)
  • Drug Master File Annual (DMF) Reports and Amendments
  • Fast Track Applications
  • Investigational Device Exemptions (IDE)
  • Investigational New Drug Applications (IND) and IND Amendments
  • Marketing Authorization Applications (MAAs)
  • Meeting Information Packages
  • New Drug Applications (NDAs), Amendments, and Supplements
  • New Drug Submissions (NDSs)
  • Orphan Drug Applications (ODAs)
  • Premarket Approvals (PMAs)
  • Pre Market Notifications (510k)

Compiling and Publishing Regulatory Submissions

Compilation, assembly, and final quality assurance review of regulatory document is completed by our regulatory submissions specialists. As each volume of the submission is completed, it is reviewed for correct pagination, tabulation, organization, and appropriate inclusion of all text pages, tables, and data displays.

Trained Staff

Our staff has extensive experience preparing and submitting all types of regulatory dossiers. Foremost in the minds of our staff is the idea that preparation for a successful regulatory submission must begin early in the development of a therapeutic. We strive to partner with you early in development in order to ensure that the regulatory actions can be firmly supported by the development program. In addition, we have broad experience in interacting with regulatory agencies to obtain general agreement on the content and format of applications. Our regulatory personnel are also specifically trained in the following areas that serve to expedite product development and ensure compliance in marketing applications.

  • Coordination of documentation such that it can be maintained/retrieved/compliant for products seeking international approval (e.g., US, EU, Canada).
  • Utilization of the Core Data Sheet throughout all stages of product development.
  • Experience with current regulations/guidances and recent initiatives on Summary of Product Characteristics and US Package Inserts.
  • Experience with current electronic labeling initiatives (e.g., SPL, PIM).
  • Regulatory Associates have current training on our validated publishing software and xml coding.
  • Project teams include cross-trained individuals with electronic submissions experience.
  • Fully trained group of quality control reviewers who ensure complete compliance with FDA and ICH standards.