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Medication vials.

Regulatory Insights

The path to regulatory approval for your drug or device can be long and challenging. Let our expert advice and perspectives help you to make the journey smoother.

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Drug Development and Regulatory

Specialty vials.

Understanding regulatory lifecycle management

Understanding lifecycle management best practices can help sponsors streamline the submission process, avoid future rework and reduce confusion caused by duplicate documents.

Cell and gene therapies

Cell and gene therapies are experiencing important breakthroughs. However, because these therapies are so cutting-edge, navigating regulatory hurdles can be challenging. Learn key clinical and regulatory questions that pharma companies should consider when developing these therapies.
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3 keys to effective sponsor-vendor partnerships

Learn three keys that will help keep your electronic common technical document (eCTD) regulatory submission on track and on time.

Preparing for Successful Meetings with the FDA

FDA meetings provide sponsors the opportunity to seek out critical agency feedback, identify gaps in required data, and come to agreement on whether the studies that have been conducted are sufficient for review. Learn the top 4 ways to help ensure your meeting is a success.