Our client was developing a novel iron treatment with potential to be best-in-class for IDA. The product used nanotechnology to mimic the natural structure of dietary iron and promised superior absorption and a better side effect profile than commonly used oral ferrous iron products. The client was conducting a clinical trial in a developing country and wanted to know whether data obtained from that trial could be used by a commercial partner to support a market authorisation in the UK or in the US, or whether additional pivotal trials would be needed by regulators in those territories. The client also wanted to know whether the project could progress straight to a Phase II under current UK regulations based on the existing dataset or whether additional data would be needed to secure a CTA from MHRA.


Our regulatory affairs consultants performed a gap analysis on the non-clinical data pack for the product, with particular focus on the PK/PD profiles, toxicity and efficacy. We prepared a report of our findings and suggested that there was no need to collect additional data before submitting a CTA to the MHRA. We did highlight, however, that there were certain aspects of the developing country clinical study design that may not be translatable to the UK or US. We recommended that official scientific advice be sought from appropriate regulatory authorities.


Our Regulatory Affairs Expertise

Our regulatory affairs consultants can help you devise effective regulatory strategies to place you on the best path torward regulatory approval, helping you avoid regulatory delays and overcome critical regulatory hurdles. We also provide hands-on support, including assistance with regulatory applications and eCTD publishing. Our experts can work alongside and supplement your internal regulatory teams to solve bandwidth challenges. We can also provide interim regulatory affairs leadership during periods of transition. Additionally, our team conducts regulatory due diligence both for internal purposes as well as for external parties engaged in licensing, investment, and M&A activities. 


Additional Regulatory Affairs Case Studies