Swift support to meet deadline

National Registration in the UK

Client: UK Pharmaceutical firm
Est: 2005  Size: 51-200

Project: Empowering a UK pharmaceutical company to successfully submit an MAA and meet a tight deadline.
Summary: Dossier, electronic Common Technical Document (eCTD), gap analysis, marketing authorization application (MAA), national registration, power of attorney (POA).

This pharmaceutical company owned a generic drug that was well suited for the UK market. The problem was, the organization lacked the licensing needed to bring its product to this target area. On top of that, the company needed to submit a marketing authorization application (MAA) in a short time frame.

Bringing our faster, better, smarter approach to the situation, we leveraged our expertise in regulatory affairs to help our client overcome national registration obstacles.

Challenges

From ensuring dossier information is up to date to communicating with the appropriate national agency, preparing and submitting an MAA involves many considerations. However, in addition to these difficulties, our UK client faced an additional challenge: a tight internal deadline. 

In one short month, we needed to:

  • Organize all efforts—both those of our team and those of our client. 
  • Proactively identify any gaps in the dossier and address them before they created delays.
  • Communicate with the national authority and quickly submit a compliant MAA. 

Solution

To provide a smooth process, we obtained a power of attorney (POA). Soon, we were informing the MHRA of our client’s intention to submit an MAA as well as the project deadline. Thanks to our POA, we were able to handle all communications with the agency and respond to any comments, relaying key information to our client. Afterwards, we created a project plan. This plan outlined the overarching strategy and included key details involved in submitting the MAA—such as who was responsible for what activities; when certain actions were required; and which procedures, instructions, and timelines were involved for each module. 

We also identified gaps between our client’s documentation and the EU RMP integrated format that would hinder a successful MAA submission—risking rejection of the application and a delay in the initial validation.  As we revised our client’s risk management plan (RMP), we discovered areas where the dossier was noncompliant. We knew that—unless we addressed these gaps—our client might experience delays and fail to meet its internal deadline. We acted to correct these disparities quickly. Thanks to Arriello’s expertise, it wasn’t long before an updated and compliant eCTD was in the hands of the UK authorities.

Faster. Better. Smarter.

Through our faster approach, the UK pharmaceutical company submitted its application before the deadline. Not only that, thanks to Arriello’s better approach, our client spotted critical gaps between its dossier and the EU RMP integrated format—which empowered the organization to execute critical updates to avoid delays. 

Finally, with Arriello’s smarter approach, our client gained a clear project plan...a strategic blueprint that supported a seamless experience for the MHRA.  A tight time frame notwithstanding, our UK client successfully completed an MAA submission—and avoided pitfalls in the application process. 

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