As a clinical stage company gearing for BLAs and MAAs, we needed support with clinical trial, regulatory strategy for our Heme-Oncology program. Partum consultants were responsible for EU strategy and CTA submissions for multiple studies from Phase 1 to pivotal trial. They managed the activities well and made great links with the CRO supporting clinical operations to maximise efficiencies and synergies. The regulatory knowledge, pragmatic approach, and ability to clearly articulate ideas are essential qualities for any successful program and Patrum team helped us overcome challenges to get regulatory submissions and compliance activities completed in a timely manner.

The consultants really work by adapting and forming strong relationships, both internally/externally with vendors and are not afraid to roll up the sleeves and meet the problem in the trenches. Partum will be our go-to regulatory consultancy and I highly recommend them.

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Partum worked for us on regulatory interactions and dossier preparation of two parallel MAAs. Partum provided us with support on various regulatory activities and provided dedicated resource support for our project throughout the procedure. The consultant from Partum led the responses for both the MAAs with flexibility, organization skills and managed exceptional quality deliverables despite the short time was never compromised. The consultant showed deep understanding of the topics leading the team not only from regulatory perspective but also from scientific point of view and it was really evident that the team really trusted in her competences. We were pleased to with her skills to mitigate and lead the team in really complicated situation. She has pragmatic solutions and proposal that comes from her experience and analytical thinking. Overall working with the consultant and partum team is a pleasure as we continue to work with them, for sure recommend Partum for their regulatory competence and leadership.

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We were looking for a Regulatory help to manage the EMA centralised submission of our asset for treatment of iron deficiency anaemia (IDA) and lead the response strategy and submission. Despite short onboarding process, Senior consultant from partum quickly familiarised with the dossier, interacted with external partners on behalf of our organisation and spotted out the potential challenges. Consultant defined the regulatory strategy for each EMA question and the content of the response. The scientific input in terms of efficacy, non-clinical and labelling matters were invaluable. We were able to benefit from the medical writing service and front-loading the dossier preparation.

The senior consultant was knowledgeable, committed and results oriented. I wholeheartedly recommend Partum. They are able to build a structure, coordinate the activities and handle historical complicated regulatory filings.