Efficient and effective regulatory interactions are critical to advancing your product successfully through each development milestone, from the early stages of drug development through to marketing authorisation.
Regulatory affairs is a broad field that encompasses regulatory consultancy (expert advice to optimise regulatory strategy), operational aspects (i.e., collating submissions and engaging with regulators), and regulatory writing (preparing and generating regulatory documentation).
For a more detailed overview of our regulatory affairs consultancy services, please refer to:
Documents are compiled into a complete submission that complies with all relevant regulatory requirements.
The compiled documentation is then submitted to the appropriate regulatory agencies or bodies to obtain approval to conduct the clinical trial.
Regulatory approval is obtained for any necessary updates or amendments to the trial. Interim and annual reports, safety updates, and other required documentation are submitted in accordance with ICH-GCP guidelines.
Study results are submitted to the relevant authorities in accordance with regulatory requirements.
In the context of clinical trials, we provide regulatory writing services across all key stages of the study:
1. Before the start of the trial – writing core clinical trial documentation such as investigational medicinal product dossiers, investigator’s brochures, protocols, and informed consent forms.
2. While the trial is ongoing – updating core clinical trial documentation, as necessary. Writing interim or annual reports, safety reports, etc., as required by ICH-GCP.
3. After the clinical phase of the trial is completed (or the trial is terminated) – writing clinical trial reports, including lay summaries of trial results, and updating safety reports.
Additional Services:
Preparation of regulatory documents
Common technical document modules
Paediatric investigation/study plans
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