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Changes the life sciences industry is going through, resulting in digital transformation within the organisations

How have regulatory business processes been changing during the past few years?

Regulatory business processes have changed a lot in the past few years and are ongoing to change in the future. eCTD submissions becoming mandatory in many regions and additional data that must be submitted to the regulatory authorities are just two of the many changes the life sciences industry is going through, resulting in digital transformation within many organisations.

Do you see the complex regulatory landscape changing? How could regulatory affairs professionals optimise their overcomplicated strategies?

The introduction of IDMP with the DADI project for electronic application forms will bring complex regulatory landscape changes. Additionally, eCTD 4.0 will be introduced as the next major submission standard which will also require changes in the SOPs of the regulatory businesses. In order to manage the increasing amount and volume of data and documents that will have to be managed in order to remain compliant, organisations will have a growing demand for Regulatory Information Management platforms such as EXTEDO pulse.

What are the current regulatory requirements that empower or challenge the adoption of new solutions?

IDMP and eCTD 4.0 will be the reason for significant changes. The implementation of IDMP can be a huge challenge if not implemented professionally in pharmaceutical companies. Organisations must create new strategies and processes to keep all the required data up-to-date. Excel may no longer be a solution, but end-t-end Regulatory Information Management Systems will be needed to keep track of the increasing amount of data. Document management solutions as part of such a platform will play a more critical role in the future, with the ability to automatically generate eCTD submissions. These capabilities of a RIM platform will reduce the effort that is needed for every step of the regulatory submissions, and it is required to manage the increasing tasks for regulatory affairs departments.

Discover more about EXTEDOpulse for Regulatory Information Management

EXTEDO is also partnering with us at our 2nd Annual Pharmaceutical Regulatory Affairs Summit on 26th – 27th October in Austria Trend Hotel Ananas and will share their case study on eCTD 4.0 - No Need to be afraid.

EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). We focus on optimising our clients’ eRegulatory business processes and provide solutions covering the entire regulatory landscape:​

  • Planning & Tracking​
  • Document Management​
  • Product Registration​
  • Submission Management​
  • Safety Management​

Today, EXTEDO enables more than 35 regulatory authorities and over 1000 maintained customers across 65 countries to deliver Effortless Compliance™. Our clients range from small CROs to large multi-national pharmaceutical organisations, and we cover industries from biotech to homeopathics, and medical devices to crop sciences. ​

Our mission of Effortless Compliance™ ensures that organisations can spend more time doing the things they want to do, rather than the things they have to do.​

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