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REGULATORY AFFAIRS

Let Regulatory Affairs Transformation bring you into the future

The regulatory requirements are constantly changing; we can help you use IT to comply with existing and new regulations

Regulatory Affairs requires an IT set-up that copes with the increasing complexity and makes it easier to manage. Through the transformation to a unified platform, you break down your silos, standardize your data and optimize your business.

What is Regulatory Affairs Transformation?

During the past decade, Regulatory Affairs has undergone significant changes. Technology has evolved, yet with increasing requirements from authorities the challenge is to maintain legacy systems which today are complex and costly. Many RA departments have a desire to transform their business through new technology, and to reap the benefits of innovation and IT optimization. The challenge is how this is governed and to define the roadmap for this transformation.

Most RA departments operate individual, using fragmented and not integrated IT applications, such as Electronic Document Management System (EDMS), Electronic Common Technical Document (eCTD), Regulatory Information Management System (RIMS) and labeling systems to embrace the many varied tasks involved in RA.

While these IT solutions for the different RA processes may be robust, they exist independently, resulting in the creation of many closed-off and expensive “silos” of data. These silos are counter-productive to what really matters: Getting new products to the market.

With a unified platform it is possible to transform Regulatory Affairs processes by merging these systems into one platform, standardize data models and use cases and thus improving both compliance and operational efficiency.

What are the benefits of digital transformation in RA?

Having many silos inhibit the access to data and ultimately results in unrealized potentials for market development. RA transformation challenge this paradigm.

Specifically the benefits of RA transformation are:

EMA and FDA are increasingly requesting submission of structured data in addition to documents. RA transformation will bring documents and data together so that the information in the submissions is aligned and transparent, regardless of the format and across the application landscape.

RA and the other critical areas within the value chain such as Clinical, Manufacturing and Pharmacovigilance can more easily exchange and re-use data to support business processes and the regulators’ enquiries.

With separate systems and scattered data, it is difficult to monitor regulatory operational activities. By contrast, RA transformation will allow for better analytics with the purpose of identifying challenges and bottlenecks in the RA processes.

With separate systems and scattered data, it is difficult to monitor regulatory operational activities. By contrast, RA transformation will allow for better analytics with the purpose of identifying challenges and bottlenecks in the RA processes.