Get instant access to the Survey that everyone was talking about at RAPS Euro Convergence – the 2024 RAPS & Celegence Regulatory & Readiness Survey.

Celegence-RAPS

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

Pharmaceutical Industry Regulatory Readiness & Resources
2024 Survey Report

Medical Devices Industry Regulatory Readiness & Resources
2024 Survey Report

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 – download the report to get the full picture:

  • Top two Regulatory challenges for both pharma and medical devices:

    1. Time/bandwidth
    2. 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.
    • 52% plan to invest further in tech for IDMP in the next year, and 55% in the next two years
    • 38% cited ‘insufficient bandwidth’ and 26% cited lack of in-house expertise in specialized areas on reasons to outsource medical writing in pharma
  • Medical devices:

    • 58% of Regulatory Affairs leaders will spend more on MDR/IVDR maintenance in 2024
    • 23% are incorporating AI into the company’s medical device product today
    • For outsourcing services, 35% plan to outsource for Regulatory submissions and 32% for CEP/CER consulting.

Get access to the full report now!

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Thank you to all who contributed to the survey and had your say. We invite you to download the report and also engage in a conversation on the direction of regulatory affairs.