LEVERAGING PROVEN REGULATORY EXPERTISE AND GUIDANCE

Virtus provides the knowledge and direction needed to bring high quality regulatory-compliant medicines to market.

We have more than 30 years collective regulatory expertise in the generic pharmaceutical industry, with experience spanning from solid to parenteral dosage forms, prescription to non-prescription pharmaceuticals, and dietary supplements to medical foods. Our regulatory team has worked with leading brand and generic pharmaceutical companies.

The organization prides itself on being a flat structure that is flexible, collaborative, focused, self-directed and highly motivated with a strong sense of teamwork.

Key Activities

  • Preparation of new ANDAs
  • Response to deficiency letters
  • Lifecycle management for approved applications including Annual Reports and Supplements
  • Management of Pharmacovigilance Programs
  • Development/Maintenance of labeling: SPL and drug listing

For more information about Virtus Regulatory, please contact Vishal K. Gupta, PhD, CSO and SVP, BD&L at vgupta@virtusrx.com