Regulatory Consulting Services

FDA Regulatory Consulting Services for Biopharmaceuticals

At Vivaxa, we specialize in expert FDA consulting, providing cutting-edge strategies and comprehensive support throughout your product development journey. Whether you're a small startup or a large enterprise, we are dedicated to helping you navigate the FDA approval process with ease and efficiency, ensuring faster time-to-market for your product in the United States.

Our experienced in-house team takes the hassle out of regulatory submission, ensuring that all documents are compliant with FDA requirements. We expertly handle eCTD submissions for IND, DMF, NDA, FDA 510(k) applications, and more, allowing you to focus on what matters most—your product’s success.

We also offer strategic guidance on accelerated pathways such as Fast Track Designation, Breakthrough Therapy Designation, and STAR, helping you expedite your regulatory approval. Additionally, our team can assist with authoring and developing Pediatric Investigational Plans to ensure compliance with FDA guidelines.

Partner with us to streamline your FDA submission process and bring your innovative biopharmaceutical products to market faster and with confidence.