Pharmaceuticals

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.

Pharmaceutical marketing and labeling

The marketing and labeling of pharmaceutical products is highly regulated as well. Copy for product information and marketing sheets and websites must be straightforward, precise, unambiguous, and error-free. All content must go through a stringent legal and regulatory review. Even the design parameters are proscribed.

This can make crafting documents, microsites, and social media campaigns slow and cumbersome.

Single-source, end-to-end

Aptara’s solutions include multiplatform content storage as well as compliant document design, production, and delivery. Our “lights-out” publishing technology automates the review and approval process. And our back-office services—everything from accounts payable to shareholder support—can be tailored to the specific needs of pharmaceutical companies.

With a comprehensive suite of services from a single provider, Aptara can expand your capacity while reducing costs, maintain—or improve—quality, and ensure compliance.

 

For more information, please reach healthcare@aptaracorp.com