Review and gap analysis of a technical file

Challenge

A pharmaceutical company wanted to launch a drug delivery device in the United States. The product was approved in the EU and Team Consulting was commissioned to review the technical documents and ensure its suitability for a submission to the FDA.

Approach

Drawing on from many years of drug delivery device experience, we put together a team comprising of quality engineers, risk management experts, device testing specialists and human factors consultants to conduct a review of the available documents. In addition, we proposed options to fill any gaps in data or documentation that could prevent or delay FDA approval.

Outcome

The combination product was approved by the FDA in a timely manner with minimal changes to existing documentation.

A pharmaceutical client, based in the US, asked if Team Consulting could provide support during their drug delivery programme. The project focused on documentation, risk management and human factors.

The programme was challenging as the drug delivery device was developed in the European Union to meet EU regulatory requirements and the key stakeholders were based in both the EU and the US.
Team were commissioned to conduct a gap analysis on the existing technical file, this included reviewing usability data, test data, risk management and making recommendations to ensure FDA approval as soon as possible.

Medical device gap analysis

We started by meeting with the client’s key stakeholders, including EU-based licence holders and technical leads. We gained a thorough understanding of the development history of the device, technical file structure and areas of concern.

Following this meeting, we conducted an initial assessment of the technical file, although this focused on the critical documents identified by the client. We also reviewed a wider selection of documents to ensure these would be suitable for submission to the regulators.

Following the initial review, Team conducted a further in-depth assessment of documents that could be improved for submission, these included documents relating to device testing, human factors activities and risk management activities.

Remediation activities

Our assessment allowed us to identify several aspects which needed to be remediated. We provided an update to the client’s risk management file to ensure compliance with current standards. Our risk management experts facilitated several risk assessments combining stakeholders based in the UK, EU and at various locations in the US.

In addition to the review of the technical documentation, the client was in correspondence with the FDA and Team supported the drafting of questions and review of their feedback.

At the time, there was uncertainty whether the FDA would require a human factors study based in the US. To minimise any potential delay, Team conducted two parallel work streams. One group collated and reviewed the data from the EU to demonstrate that the device was safe and effective, avoiding the need to conduct a US summative study. The second group created a summative study protocol and prepared for a US study to ensure this could be conducted, if required.

Outcome

Team liaised with all the key client’s stakeholders, pinpointing gaps in both usability and risk management data and provided support to create the required regulatory documentation. Our streamlined approach allowed our client to successfully submit to the FDA. The submission was both timely and came with minimal changes.

At Team, we are focused on building good, long-term client relationships and this is a really good example of that in practice. Team was already supporting this client with one development programme and they asked if we could help them with another one. Our understanding of their working practices, systems and personalities helped us to complete this project in a timely manner.

Mark Di Cioccio, Head of Quality Engineering, Team Consulting

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