Regulatory writing
High-stakes regulatory submissions demand rigorous attention to detail. At Auxa Life Sciences, we possess deep regulatory writing expertise, and take immense pride in the meticulous quality of the documents we produce. ​​​​
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All our writing processes are governed by ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines, regional health authority regulations (including US Food and Drug Administration and European Medicines Agency), and robust internal standard operating procedures.
We at Auxa will work closely and collaboratively with you to ensure your documents are just as you need them to ensure seamless regulatory review.
Study protocols
We develop and fine-tune your trial concept and then bring it together into a clear, concise, structured, and compliant study protocol. We offer support with the development of Phase I-IV clinical and non-interventional study protocols as well as protocol amendments.
Study reports
We are experts in the preparation of clinical and non-interventional study reports (both interim and final). We will work closely with you throughout draft rounds to ensure your key study results are accurately and clearly presented and in accordance with regulatory authority requirements. We prepare subject narratives and can also develop (or update) your in-house study report template.
Investigator's brochures
We develop and/or update investigator's brochures, ensuring clear and concise compilation of all the known clinical and non-clinical data for your investigational medicinal product.
Application dossier modules (in CTD format)
We have extensive experience writing clinical (2.5 and 2.7) and non-clinical (2.4 and 2.6) CTD modules for both EU and US submissions. We will work closely with you according to carefully designed timelines ensuring timely delivery of submission-ready modules.
Aggregate safety reports
We have a wealth of experience developing safety reports, including Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs).
Patient information and informed consent forms
We develop clear, concise, and ethically sound patient-facing materials including patient information leaflets and informed consent forms.
