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Regulatory Affairs Blog Posts

June 22, 2021 Regulatory Affairs

Understanding Cybersecurity Threats to Medical Devices

In this post, we talk about medical device cybersecurity, FDA's pre-market and…

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June 17, 2021 Regulatory Affairs

How to File Post-Approval Changes to an NDA or ANDA

The range of variables and decisions that go into changing a previously…

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June 9, 2021 Regulatory Affairs

United in Diversity: Six Tips for European Batch Release

Navigating the regulatory landscape can be challenging, but implementing these tips will…

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June 7, 2021 Regulatory Affairs

Meet the Expert: Anchal Choudhuri

Our “Meet the Expert” series introduces you to our team of experts…

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June 1, 2021 Regulatory Affairs

Best Practices to Reduce Impurities in Generics

Drugs can be rejected due to impurities. In this article, we take…

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May 26, 2021 Regulatory Affairs

The Key to Understanding Pricing and Reimbursement in the Nordics

Choosing the right Pricing and Reimbursement strategy, and doing so early in…

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May 18, 2021 Regulatory Affairs

How to Prepare for the Three Type B Meetings with...

Preparation & planning are key elements in conducting successful meetings.

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May 16, 2021 Regulatory Affairs

How to Understand and Avoid Common Phase 3 Failure Points

To succeed with your drug development program, you need to understand how…

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