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Regulatory Readiness and Resources Survey Report 2024

Get instant access to the survey report that regulatory professionals are talking about: the 2024 RAPS & Celegence Regulatory & Readiness Survey.

698 regulatory professionals weigh in on the direction for the medical device and pharmaceutical industries. See the interesting findings – download it now.

Celegence partnered with RAPS, Regulatory Affairs Professionals Society, on a survey to Regulatory Affairs professionals. We looked at topics around current challenges, investments, technology, processes, staffing, skillsets and future outlook to better understand industry direction.

Given the strong response rate and interest, we were able to compile the results into two distinct segments:

1. Pharmaceuticals (includes Pharma and Combination Products)

2. Medical Devices

With two distinct reports available, one focused on the Pharmaceutical Industry and one on the Medical Device Industry these reports will allow you to gain an understanding of what issues and challenges companies in the Life Sciences Industry face in 2024.

There were a few questions specific to each segment, and several questions were the same for comparison. Here are a few takeaways –

Top two Regulatory challenges for both pharma and medical devices: Time/bandwidth Cost/managing budget

In fact, 77% in Medical Devices and 55% in Pharma said they have insufficient resources to complete all of 2024 priorities

Pharma: 81% see the benefit of eCTD v4.0 and over two-thirds are planning submissions in eCTD v4.0 format; 60% are planning an assessment in v4.

Medical devices: 58% of Regulatory Affairs leaders will spend more on MDR/IVDR maintenance in 2024

For further regulatory assistance or queries on how Celegence can support your organization, reach out to info@celegence.com today.

Get access to the full report!

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