Regulatory Consulting

Experts in Evolving Life Science Regulations

Validant provides the seasoned guidance you need to effectively navigate complex regulatory requirements throughout the drug or device lifecycle. We empower you with perspectives, strategies, and tools to confidently progress down the right regulatory pathway, avoiding compliance pitfalls.

In fact, many of our partners and consultants have worked inside global health agencies, and we maintain close relationships with relevant regulatory bodies around the world to ensure accurate interpretation of current standards and to keep a pulse on what’s coming next.

Our Regulatory Practice offerings include:

Specialized in Regulatory Approval Pathways

Through our partner company, DataRevive, Validant clients have unmatched access to world-class regulatory expertise. DataRevive’s team includes a truly one-of-a-kind roster of former FDA CMC and clinical professionals and industry operators who are deeply versed in critical regulatory pathways globally.

They provide particular expertise in expedited pathways including Fast Track, Breakthrough Therapy, Orphan Drug Designation (ODD), and others.

Learn more about DataRevive’s consulting capabilities here.