To help you out in your submissions to US FDA, we prepared a free checklist. This free FDA PDF specifications checklist can help you reduce risk of non-compliance in your submission content preparation for FDA.
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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
eCTD 4.0: Key Changes & Impact on Submission Content Preparation Read More »
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
What is Document Rendering, and what can it mean for your business? Read More »
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
How to reduce regulatory content creation issues? 4 tips. Read More »
Pharmaceutical and biotechnology companies spend a lot of effort in the R&D process of a new medicine or a product. As every stage must be properly documented, a typical R&D process generates huge quantities of documents. And in a lot of different formats: Word, Excel, PowerPoint, text files, scanned PDFs, image files and many more.
Free checklist for PDF format specifications for FDA submissions Read More »
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,
3 tips to save time and reduce risk in regulatory submissions Read More »
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
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 »
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
Refusal to File (RTF) and how modern rendering can reduce non-compliance risk Read More »
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,
How to speed up PDF conversion by 10X in 2021 Read More »
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