Case Study: VERO Biotech achieves accelerated FDA approval and rapid market launch with Advarra Consulting

VERO Biotech Enlists Advarra Consulting to Provide Guidance for FDA Approval

VERO Biotech, a company developing an inhaled nitric oxide combination drug and delivery device for NICU patients, faced the complex regulatory challenge of filing a 510(k) for the device component and an NDA for the drug while contending with gaps in internal infrastructure and cGMP compliance. To navigate the FDA process and build the necessary quality and project-management systems, VERO Biotech engaged Advarra Consulting for a comprehensive strategic and tactical plan.

Advarra delivered strategic advisory, operational support and integrated project teams—providing quality management systems, CMC and manufacturing experts, technical writers, and FDA communication practitioners—to complete a world‑class NDA and device filing. With Advarra’s support VERO Biotech obtained FDA approval in three years, launched the combination product within five months of approval, accelerated time‑to‑market and reallocated resources to save time and costs (reported as potentially millions of dollars).

VERO Biotech

Marc Morin

Chief Financial Officer