Global Regulatory Affairs

Document preparation is key to ensuring that your products get to market as quickly as possible.  

We fully understand the importance of getting them right first time. 

Professional CTD medical writing is one of the most important aspects of what we do. It impacts on many activities and unless done to the highest standard, has significant implications. As part of our company philosophy, we have sought many experts in the field of medical writing to work in our offices.

Our medical writers are highly proficient in preparing Module 1 to 5, ensuring that your dossier shall be submission and registration ready. 

 

Our writers are based in Europe, highly experienced and work with complete diligence to ensure that all information submitted is both accurate and reliable.

We can assist you in gap analysis of your existing documentation and in preparing both clinical and non-clinical overviews. Our in-house experience in drafting Module 2.4 and Module 2.5 is extensive, so we can guarantee compliance with scheduled deadlines.

Our medical writing service can complement any of the other regulatory services that we provide. We offer a one-stop solution using the most advanced technology to ensure that your company and products comply with the requirements of the competent authorities.

If your dossier is in a previous format and needs to be revised, prepared or converted to the electronic Common Technical Document format, we can assist in preparing and submitting the dossier on your behalf.

Our teams of experts are duly qualified to prepare your regulatory submission documents, making your dossier ready for registration in any market you may wish to access. We will work with your previous NtA, NeeS or CTD files, conduct a gap analysis and then update the contents to the latest standards.

We can prepare all components of the Common Technical Document (CTD) – Chemistry, Manufacturing and Controls (CMC), non-clinical and clinical documents – whether for NCEs or approved products:

  • Module 1.6 (environmental risk assessment)
  • Module 1.8 (pharmacovigilance)
  • Module 2 – Clinical and Non-Clinical Overviews + Summaries
  • Module 3 – CMC
  • Module 4 – Preclinical
  • Module 5 – Clinical

Our medical writers are experienced in most therapeutic categories, allowing us to cover nearly any kind of clinical and non clinical requirement.

Moreover, we have invested in access to databases such as Embase, allowing us to provide you with a wide and deep range of articles to support this activity. Furthermore, we have a dedicated network of experts for any national literature searching.

Finally, we use the most advanced software for electronic submissions in the standard eCTD format. 

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If you are interested in our service please contact us for more information.

Telephone+353 125 44033
Email: marketing@arriello.com

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