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Regulatory submissions

Navigating the Regulatory Submission Process

Regulatory submissions are a very critical milestone in the life sciences industry. They are literally the translation of (mostly) 10 years’ worth of R&D work into success.  Therefore, navigating regulatory submissions is a critical and often complex hurdle.  The regulatory submissions process involves 5 main stages, being: Pre-submission Application preparation Submission & review Addressing deficiencies […]

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The Risks of Manual PDF Manipulation in Life Sciences Compliance (and the benefits of automation)

Introduction Welcome to a journey through the complexities of PDF compliance within the life sciences. This article aims to enlighten you on various critical aspects: Gaining insights into the complex process of manual PDF preparation for compliance. Learning about the numerous challenges and limitations associated with manual PDF manipulation. Discovering how automation revolutionizes submission content

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Automating submission document preparation in OpenText Documentum with DocShifter

Automation in OpenText Documentum with DocShifter

1. Rendering is more than creating a PDF. No matter which document management system you use. Traditionally, rendering has often been viewed as a straightforward process of converting one file format into another, like turning a Word document into a PDF. Many people simply associate rendering with this basic format conversion, and that’s where it

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4 Situations You Probably Faced in Regulatory Operations (and practical tips to overcome them)

For this month’s edition, we knocked on Daniel Capion‘s door. Daniel is a documentation expert with +20 years of experience from biotech, mid-sized and big-pharma industry as well as medical device knowledge. We interviewed him on 4 situations you have probably faced yourself in regulatory operations, and practical tips to overcome them. Enjoy the read! Challenges and

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eCTD 4.0: Key Changes & Impact on Submission Content Preparation

Following our previous “What’s next after eCTD?” article, this paper aims to provide a brief update on the next major version of eCTD, version 4.0. Since 2003, eCTD has been adopted by an increasing number of Health Authorities around the world. The standard has evolved incrementally in that time. eCTD 4.0 will introduce significant updates

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Creating the right environment for structured and unstructured data to co-exist

There’s a lot of talk about structured information and how it will solve all our problems with regulatory submissions. If you look at initiatives such as IDMP and EMA’s Digital Application Dataset Integration Project (DADI) or further back, FDA’s Structured Product Labeling, there are good examples of health authorities getting at least some information into

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A Case Study in Regulatory Operations: Digital Transformation of the Workforce

If you work in Regulatory Operations, you are probably knee-deep in transformation. Whether you are upgrading your entire RIM system (or parts of it), or migrating to cloud-based solutions, testing and implementing automation of repetitive and manual tasks, and preparing for IDMP, CTR and data submissions in general, it probably feels like change is everywhere

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3 tips to save time and reduce risks in regulatory submissions in Life Sciences

3 tips to save time and reduce risk in regulatory submissions

How can you speed up the process of getting your medicinal products approved by health authorities? At the same time, how can you reduce the risk of submitting PDFs that are not complying with technical requirements in your regulatory submissions? Our tips will help you streamline the whole regulatory submission process. For Life Sciences companies,

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Frequently asked questions on the eCTD format (Part 1)

Frequently asked questions on the eCTD submission format (Part 1)

This article answers the most frequently asked questions on the electronic common technical document submission format. A regulatory submission for a Healthcare or Life Sciences product includes all sorts of documentation and information that is submitted to a regulatory agency for: review notification or in response to a request for additional information What are the

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