Moving fast on a MHRA application
before Brexit deadline.

Full Regulatory Support for MHRA application.

Client: UK Pharmaceutical company
Size: 13-50

Project: MHRA package preparation and submission for UK Pharmaceutical company.
Summary: Gap Analysis, documentation preparation, cloud storage system and additional consultancy.

Arriello was approached to help with an MHRA application with a very short six-week preparation phase. Our proactive and talented team not only completed the contracted gap analysis on the scope (M1 and M3) but went beyond (M1-M5 inclusive) to ensure a successful submission, made possible through excellent attention to detail and a commitment to exceed client expectations.

Challenges

With Brexit looming large on the horizon, we were tasked with package preparation and submission in just six weeks – a very tight deadline that required our unique expertise.

The first challenge was the gap analysis for the M1 dossier: some documents had expired and/or contained incorrect information. A subsequent check of the M2, M3, M4 and M5 documents revealed certain issues. For example, whilst reviewing the M3 dossier, we realised some excipients tradenames were stated, and in order to prevent filing additional variations when those wanted to be changed, we recommended to remove the extra details from the dossier.

Further complicating the process was the fact some documents were not available at all, or at best delivered later during the package preparation. This added to the sense of urgency, as many documents in the later modules required changes (i.e. M3) before submission. The quick turnaround made open and responsive communication vital to success, but unfortunately an already tight schedule on the client-side made getting the answers we needed difficult, forcing us to accept that further delays were inevitable.

Solution

With a proactive team, unfazed by the time frame and committed to delivering excellent attention to detail, our gap analysis looked beyond the scope of work (M1 and briefly M3) and extended to all documentation (M1-M5 inclusive) that could have been unvalidated, expired and/or inaccurate. Full transparency of all documentation from the start meant our follow up quickly identified what was required and allowed for teleconferences or additional project demands to be swiftly set in motion.

However, simply requesting documentation was insufficient for our energetic team. We made sure we informed the client of all the possible risks related to the missing MHRA submission, and the possible impacts on the final process. To speed up the information exchange, our team uploaded all documentation to Arriello’s cloud-based storage system. Being remotely accessible made storage not only easy for the client to share what was needed as it became available to them, but helped track files as and when they were added – allowing a more open workflow for all involved.

Although more gaps were identified than originally expected, our team updated all dossier sections and worked with the client to set realistic targets and expectations, while ensuring the promised deadline to the client was respected and delivered on.

Faster. Better. Smarter.

Arriello’s faster, better, smarter approach, allowed our client to submit before the deadline, and successfully meet the MHRA (UK) requirements.

We identified not only the scope, but what would be needed across the MHRA application, to ensure that preparations kept moving at the faster pace Arriello is known for. Our outstanding attention to detail and proactive team put into place a ‘best approach’ thinking from the outset, which meant an overall better outcome for the client (the final MHRA resulted in only one comment). And Arriello’s cloud-based system once again proved the smarter way to share and access information in a transparent and timely manner.

 

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