A Medical Writing project covering nine non-clinical modules (m2.4) for two products in different pharmaceutical forms and dosages.
Providing support for market entry for novel products with non-clinical modules.
Preparation of high-quality non-clinical texts, based on deep gap analysis of the content, literature search and analysis.
The company was launching medicinal products in nine EU states and had to complete the requisite paperwork requiring new non-clinical modules in just one month. Incorrect submissions can lead to the issuance of Letters of Deficiency, so to avoid this potential error the company engaged us, their long-time partner, to prepare high-quality non-clinical modules for the relevant dossiers.
We immediately faced some significant hurdles: the old dossier provided was occasionally inconsistent with regards to pharmacokinetic and toxicology studies. Furthermore, although the versions were written as “well established use”, the client intended to submit an updated dossier, declared under Article 10(1) as a generic application, which would require the reference product used during the bioequivalence studies.
We assembled a dedicated team consisting of a Regulatory Affairs writer, Project Manager, and Behaviour Driven Development Manager. Taking the modules provided by the client, this team then performed a deep gap analysis of the content, literature search and analysis, and then put pen to paper.
Arriello’s experts rewrote the modules – virtually from scratch – eliminating any discrepancies in the agreed strict one-month timeframe. Finally, we performed a comparative analysis between the previous and the new version of the modules.
Faster. Better. Smarter.
Arriello completed all of the work within the agreed timeframe and succeeded in delivering high-quality, non-clinical documentation. Our team communicated the complex non-clinical module requirements in a simplified and streamlined way, enabling the client to share all necessary data to create the properly updated modules 2.4.
We also demonstrated flexibility by providing unwavering support for the client’s changing requests and succeeded in guiding the client to the most suitable product strategy.
The result was a Marketing authorization application in line with internal plans, which also avoided Letters of Deficiency from the EU authorities. The products reached the markets much faster – in just two weeks.
Arriello’s client-centric approach, flexibility, and proactivity enabled us to provide a high-quality consultancy service along with regulatory affairs and pharmacovigilance activities, which eliminated unnecessary steps and ensured 100 percent of the tasks were completed first time without incurring additional costs or losing time.