Regulatory Affairs

Regulatory support is essential to the drug development process, and EMEACR is devoted to serving as your regulatory partner for the success of your clinical development program.

Our careful attention to detail and an excellent relationship with the regulatory authorities helps to expedite the regulatory review process and to shorten drug development timelines.

Our Regulatory Team is able to publish regulatory submissions in compliance with FDA, ICH and European requirements.

Our services include:...
  • Investigational New Drug Applications (INDs)
  • New Drug Applications (NDAs)
  • Abbreviated New Drug Applications (ANDAs)
  • Biologic License Applications (BLAs)
  • New Drug Submissions (NDSs)
  • Abbreviated New Drug Submissions (ANDSs)
  • Clinical Trial Applications (CTAs)