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Why pharma teams are drowning in submissions and what to do about it – Part two

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Welcome to part two of this blog series. In the first part we’ve explored the current state of the pharma industry and how the regulatory submissions process has been impacted. We’ve looked at KPIs that sponsors and CROs can monitor to ensure regulatory submission success, and we’ve analyzed the current landscape, looking at the internal […]

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Why pharma teams are drowning in submissions and what to do about it – Part one

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Regulatory affairs (RA) teams are under pressure more than ever before. Faced with a growing demand for pharmaceuticals, cumulative legislative changes and an approaching steep patent cliff, sponsors are struggling to find new ways to modernize, innovate and deliver therapeutics to market faster.   The greatest challenge isn’t just the volume of work, but the unpredictable

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How to accelerate pharma regulatory success with prepopulated templates

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Pharma organizations can spend as much as $4.54B to bring a single molecule to market. The costs are only rising, while regulations are becoming more complex. This pressures organizations to manage extensive portfolios and afferent regulatory dossiers with fewer resources. When regulatory submissions take too long or are not accepted, organizations incur significant costs, from

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RWS, Fonto One, and Structured Content Authoring (with AI) go to Washington!

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DIA’s Annual Global Meeting is always a great opportunity for sponsors, service providers and health authorities to learn from one another, and this year’s meeting was no different. This was certainly not my first DIA Global Meeting, but it’s my first in a while as part of an organized team.   I have been working

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Collaboration on business challenges and innovations with regulatory documentation 

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On March 17, RWS hosted the Q Innovation Workshop in Basel, Switzerland, bringing together pharmaceutical industry leaders from around the world to collaborate on innovation and business challenges in the clinical and regulatory landscape. The interactive event provided a forum for in-depth discussions on structured content authoring, data management, AI automation, localization, and the future

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Chip Gettinger at BioTechX

Accelerating time-to-market with structured content: a new approach for global pharmaceutical companies

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The evolving landscape of global pharmaceuticals presents a significant challenge: how to accelerate the time-to-market while maintaining regulatory compliance and content consistency across regions. Adopting structured content solutions offer a transformative approach, enabling companies to manage information more effectively and facilitate faster submissions to regulatory agencies such as the EMA and FDA. At BioTechX in

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Embracing the future of document authoring in pharma: a structured and data-driven approach

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In the fast-paced world of pharmaceuticals, the clarity and precision of documentation are not just a matter of compliance, but a cornerstone of innovation and patient safety. Structured content plays a critical role in meeting the stringent regulatory demands and the quest for efficiency. The shift towards structured content authoring is revolutionizing the way we

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Understanding structured content: definition and benefits

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In today’s digital age, the way we manage and utilize information has evolved dramatically. Conventionally, document content is unstructured, with text, figures, and tables that authors can freely arrange in the way they want to. By structuring content, we can shift from a document-based to a content and data-based approach. But what exactly is structured

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Standardize and Harmonize Product Information with Fonto: Advancing the ePI Initiative

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In the ever-evolving landscape of pharmaceutical regulations and information management, the need to standardize and harmonize product information has become increasingly crucial. At the forefront of this movement is the Swedish Medical Products Agency, Läkemedelsverket, which has recently made significant strides with their ePI (electronic Product Information) Proof of Concept. In this post, we’re sharing

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Update on national pilot study for pharmaceutical companies creating ePI

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In 2022, the Swedish Medical Products Agency (Swedish MPA) selected Fonto as the editor of choice for the creation of electronic structured SmPC’s. Over the past few months, the Swedish MPA has developed an XML template adapted for Fonto. Electronic product information In a Proof-of-Concept model, information elements are divided into categories depending on the

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