Explore the benefits of creative approaches and working with a single integrated biostatistics and medical writing team to achieve an aggressive NDA timeline.
| This week's FierceBiotech is brought to you by Veristat. |
| | | | Implementing a Creative Approach to Achieve an Aggressive NDA Timeline | | | Preparing your regulatory submission is one of the most critical milestones in the drug development process. There are always challenges that arise and threaten the timeline. It takes experience, creativity, and flexibility to overcome such challenges. | | | Learn how we helped a client prepare and write their New Drug Application (NDA) in a nine-month timeline, despite a two-month database lock delay on the pivotal studies. A creative approach with intense collaboration and commitment under the leadership of the Veristat team allowed the sponsor to submit their NDA on-time, despite the database lock delays. | | | Read the full success story to learn how. | | | |
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