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4 search results for: Refusal to file

1

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 […]

2

Free checklist for PDF format specifications for FDA submissions

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 a lot of documents. And in a lot of different formats: Word, Excel, PowerPoint, text files, image files and many more. Why is […]

3

6 unique challenges of life sciences compliance

In the highly regulated life sciences and biotech industry, companies are forced to comply with countless rules and regulations. The complexity of regulatory requirements has increased sufficiently over the last few years and is expected to grow even more in the future. Understanding the requirements and the regulatory standards is the key.