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When your identified active substance has been shown to be effective, non-toxic and non-carcinogenic in non-clinical tests, the next step will be the planning and application for clinical trials.

Dr. Haney Pharma supports companies with all the application procedures, be it in one country or in a multi-country study such as voluntary harmonisation procedures (VHP).

If required, the company translates English documents to German (or arrange for other translations) and make sure that every document that is needed is in place and gets sent to the competent authority in due time.

How long does it take for the authority to assess the clinical trial applications?

Depending on the complexity of the application, you will be on the 30 day, 60-day or 90-day-track. The numbers relate to working days of assessment.

The complete procedure will thus take an average of 96, 129 or 189 days, respectively.

How can I find a suitable contractor for clinical trials?

Dr. Haney Pharma cooperates with companies specialised in clinical trials that have many years of experience and the certification for good clinical practice (GCP).

You can rely on Dr. Haney Pharma’s service to find the best contractor for your clinical trial so that the investigations will be carried out in the scheduled time frame.