Aptara’s Pharmaceutical Services practice provides a comprehensive array of specialized services that address the specific compliance, marketing, and content-related services that pharmaceutical companies need—with the kind of razor-sharp precision that the industry requires.
NDAs from A to Z
Shareholder value is directly related to the speed with which new drugs can be patented and brought to market; bringing a drug to market means getting U.S. Food and Drug Administration (FDA) approval, which involves assembling and filing the FDA’s required new drug applications (NDAs).
After turning over your NDA creation and management to Aptara, our subject matter experts can collect the necessary data from clinical trials, then create, manage, and deliver your NDA content to FDA regulators quickly and accurately. Aptara:
Manages data collection and uploads it to a customized component content management system
- Summarizes data from charts and graphs, turning it into succinct discussions of safety and efficacy
- Adds citations from third-party medical and pharmaceutical journals via linking
- All with an impressively low error rate.