Regulatory Consulting (human drug studies)
For any trial, whether it is a phase I-IV or a non-interventional study, approval for conducting the study must be obtained right at the beginning. European guidelines lay down the timelines which must be observed, both by the applicant and by the Competent Authority or Ethics Committee. When you apply for the approval of a study in particular and receive an answer from the Competent Authority or Ethics Committee, you must ensure to reply in time. Otherwise, the application can be nullified.
We can advise on which application to choose for multinational studies (Harmonized or Mutual Recognition Procedure), ensure that the documents required are submitted in the right format and keep an eye on timelines for answers to the authorities. We can also advise on local regulations, such as the notification of local authorities about the start of a study, which is a requirement in Germany.
Quotes for submissions and other regulatory tasks can be based on a flat fee to help you plan your budget.
+49 9872 9699027
+49 9872 9699029