Nitrosamines - information for MAHs

This paper gives details on the background and recommended steps required to ensure your medicinal products comply with the latest guidance for nitrosamines.

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Software, AI and Medical Devices - What's Up?

This paper highlights just a few key points that need consideration ahead of the new Medical Device Regulation 2017/745 (MDR) being implemented in 26th May 2020.

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Pre-IND meetings - don't overlook this key opportunity for early FDA feedback

This first meeting establishes the tone of your Agency relationship, and as one of the desired outcomes, you want the Agency to gain respect for your company and your science.

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CMC US EU differencesDiffering CMC requirements: US and EU

Different CMC regulatory requirements in various regions impose obstacles when considering expansion into other markets.

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Five secrets of great publishers

The FDA’s mandate for life science companies and manufacturers to submit information in electronic
format has solidified the Regulatory Publisher’s function as being essential to the drug development
process.

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How can you effectively manage your Merger and Acquisition activities

Companies engaging in Merger and Acquisition (M&A) activities aim to gain momentum by undertaking one or a combination of the following to: Level of Regulatory Affairs Involvement with M&A Programs, Increase market share by consolidating their product portfolio into specific therapeutic areas, Replenish their previously dwindling product pipeline, Enter into emerging markets with existing and new products, Reduce costs through the consolidation of manufacturing sites.

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Managing Mature Product Porfolios - Key Challenges and Benefits

According to PwC, some large pharma companies have reported as much as 40% of their spend will be
subcontracted and that their clinical operations functions will eventually be entirely outsourced.

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