How CROs & Regulatory Service Providers save time in preparing compliant PDFs
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Author name: Paul Ireland

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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What is document rendering, and what can document rendering mean for your business?

What is Document Rendering, and what can it mean for your business?

Document rendering is viewed by many as simple document-to-PDF conversion. Nothing more. However, did you know that document rendering can actually do a lot more than just converting from one format to PDF? We will explain what additional functionality document rendering can bring to your business. Many elements can be added to PDF documents to

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How to reduce content creation issues in regulatory submissions?

How to reduce regulatory content creation issues? 4 tips.

Life Sciences organisations are required to create huge quantities of documentation to support the marketing of their products around the world. Industry standards have been put in place to ensure that Global Health Authorities receive content in a manner that simplifies the review and approval process of new medicines or devices. These guidelines do provide

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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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How do you deal with track changes in Microsoft Word when converting to PDF?

Track changes and comments don’t look consistent when you convert Microsoft Word documents to PDF?

Are you having trouble converting Microsoft Word documents containing track changes and comments to PDF? Creating consistent output when converting MS Word documents containing track changes into PDF is a big challenge. With multiple reviewers and authors working on the same document, each with their styling, getting this consistency is almost an impossible mission.  Do

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What is the role of data in regulatory submissions? Is the role of data, taking over the role of PDF in electronic submissions in life sciences?

Is data taking over the role of PDF in eCTD submissions?

The Life Sciences industry is dedicated to protecting the health of millions of individuals worldwide. The industry is also looking to improve their lives with affordable and easily accessible medicinal products. Patient and patient safety always comes first, which is why the process of bringing a drug to the market takes many years (from 8

Is data taking over the role of PDF in eCTD submissions? Read More »

Refusal to file (RTF) in life sciences: What does it mean and how to reduce risk of RTF in regulatory submissions?

Refusal to File (RTF) and how modern rendering can reduce non-compliance risk

Bringing a new medicine or a product to the market is a complex process that typically takes from 8 to 14 years. Although this process may vary from one Health Authority (HA) to another, there are some general stages that the medicine must go through before it can be safely distributed to patients. It starts

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How to speed up document-to-PDF conversion by 10x?

How to speed up PDF conversion by 10X in 2021

Enterprises work with a lot of digital formats: Microsoft Word, Excel, PowerPoint, JPEG, TIFF, PDF, PDF/A, video and audio files. All these digital files need to be converted at some point; for various reasons: standardization, regulatory compliance, digital archiving, customer communication and many more. Not an easy task, as documents live in different systems, versions,

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successful eCTD implementation in China and the lessons learned

Successful eCTD Implementation in China: 3 Lessons Learned

China is the most populous country on the planet accounting for more than 18% of the world’s population. Following the focus placed on biopharmaceutical development by the Chinese government in the last decade, the country’s global industry ranking rose from 9th largest in 2007 to 2nd in 2017.  To help expedite the review and approval

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