Case Study: MacroGenics achieves faster, FDA‑compliant eCTD submissions with Litera Microsystems' DocXtools

MacroGenics - Customer Case Study

MacroGenics, a biopharmaceutical company developing antibody-based therapeutics for cancer and other diseases, faced rising pressure to produce perfectly formatted eCTD submissions under tightened FDA requirements. To reduce the long, error-prone document drafting and conversion process and ensure adherence to company style guides and regulatory standards, MacroGenics selected Litera Microsystems’ DocXtools for Life Sciences.

Litera Microsystems implemented DocXtools to automate error checking, clean up styles and convert Word files to submission-ready PDFs, including seamless template migration. The solution sped up collaboration and drafting, cut manual formatting work for regulatory staff, helped ensure documents are formatted right the first time (reducing risk of FDA technical rejection), and freed the MacroGenics team to focus on higher‑value tasks—accelerating time to market for therapies.

MacroGenics

Vanessa Kelly

Regulatory Operations Specialist III