EMA Submissions
SERVICES

  • Compiling an EMA submission is not easy. It is a time-consuming and arduous process, and if the submission contains mistakes or inaccurate information, your product’s future may be at risk. However, if you put in the hours to make sure the submission is error free, your time-to-market will likely be much shorter.

  • In order to make sure you get it right the first time, we will combine our knowledge and experience to plan and coordinate every detail of a clear and complete EMA submission. There are many elements that go into the submission, but most importantly, a combination of administrative and technical information must be accurately presented to prevent any delays or issues with review.

  • We provide consulting services for key EMA regulatory submissions including:

  • Scientific Adivice

  • Protocol Assistance

  • Orphan Drug Designation

  • Pediatric Investigation Plan

  • Marketing Authorization Application

Regulatory Strategy
EMA Meetings
Regulatory due diligence