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30 search results for: Regulatory submission software

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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 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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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 […]

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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 […]