Regulatory Affairs

Regulatory Affairs

Before a clinical trial can be commenced it is mandatory to obtain approval from the Competent Authority and a positive vote from the ethics committee. In many cases, this step is exceedingly time-consuming and can jeopardise your scheduled targets already at the start of your project. On your behalf, our Regulatory Affairs department will be happy to prepare the applications and dossiers, make sure that deadlines to respond to queries are observed, offer advice on formal and content-related aspects, and ensure that your application is processed promptly. After obtaining the approvals and votes we will be as pleased as you when the trial can be commenced.

Our experienced regulatory affairs specialists take care of the regulatory aspects of your project with the utmost care and keep a close eye on the statutory and project-related deadlines.

  • Application for approval of a clinical trial (Competent Authority)
  • Application for a positive vote from the ethics committee
  • Preparation of the applications and respective dossiers
  • Requesting essential documents from planned trial sites
  • Submission of amendments
  • Notification of clinical trials to local regulatory authorities pursuant to § 67 AMG for German studies
  • Other notifications (end of the clinical trial, submission of study report)

Regulatory Affairs

Non-interventional studies require different regulatory reports to be sent to different bodies (to the National Association of Statutory Health Insurance Physicians [KBV], the National Association of Statutory Health Insurance Funds [GKV], the Association of Private Health Insurance Funds [PKV] and to the ethics committee) if the study is conducted in Germany.  Other regulations apply in other countries.

Our experienced regulatory affairs specialists prepare your reports with the utmost care and submit them for you.

  • Preparation of application documents for ethics committees
  • Initial notification of the NIS pursuant to § 67 (6) AMG (BfArM/PEI) for German studies
  • Submission to the ethics committees
  • Notification to the National Association of Statutory Health Insurance Physicians (KBV), the National Association of Statutory Health Insurance Funds (GKV), the Association of Private Health Insurance Funds (PKV) for German studies
  • Follow-up and final notification to KBV/PKV within the scope of the remuneration for German studies

Regulatory Affairs

A clinical trial is not always mandatory when placing medical devices on the market; in many cases, a literature review suffices, provided the latter yields sufficient clinical data proving that the medical device is safe and functional, and the risk-benefit analysis is positive. We prepare or revise your clinical evaluation for you.

If your product does not yet have the CE mark, we help you prepare your technical documentation for the conformity assessment procedure, ensure that the essential requirements are met, offer advice on the risk classification of your device, and contact the notified body on your behalf.

If a clinical trial is required, we apply for the approval or for a waiver of the approval procedure for you and take care of all reporting aspects during the course of the trial.

Our experienced regulatory affairs specialists advise you on the most expedient procedure and take care of the regulatory aspects of your project with the utmost care, while always keeping a close eye on the statutory and project-related deadlines.

  • Obtaining the CE mark
  • Risk classification
  • Literature review
  • Clinical evaluation pursuant to MEDDEV 2.7.1, Rev. 4
  • Application for approval or for a waiver of the approval of the clinical trial
  • Application for positive vote from the ethics committee
  • Preparation of the applications and respective dossiers
  • Requesting essential documents from planned trial sites
  • Submission of amendments
  • Other notifications (end of the clinical trial, submission of study report)