We are a full-service regulatory and product development consulting firm for biologics, pharmaceuticals, and medical devices. Over the past three decades, we have partnered with a range of clients, supported various products at the pre-IND and IND level, and continue our work with many of these companies in their pursuit of BLA and NDA filings with the FDA. We act as a full-service consultant for companies of all sizes seeking to bring innovative, safe, and effective products to market within the US. Our team is comprised of 8 specialty groups, able to assist at an step in the development lifecycle.
Consulting ServicesRegulatory Information ManagementRegulatory Intelligence