The Rho Regulatory Affairs Department is comprised of regulatory professionals with comprehensive experience in drug and biologics development from the pre-IND to the NDA/BLA submission phase. Our mission is to deliver quality services to Sponsors in compliance with GCP and applicable federal regulations.

We focus on providing regulatory consulting, management, and clinical study document review. Our established standard operating procedures assure adherence to GCP and governing federal regulations and provide us with the flexibility to adjust to our Sponsors' needs and expectations whenever necessary.

We are experienced in managing, writing, reviewing, and compiling regulatory documents and dossiers including:

In addition to ensuring compliance of regulatory documents, Rho's regulatory team has extensive experience managing communication with IRBs and the FDA. Working effectively with regulatory agencies can reduce time to market and conserve patent life. Whether providing expert advice, planning meetings, preparing premeeting briefing packages, or facilitating communication between the Sponsor and the FDA, Rho's regulatory professionals guide you through each step of the process.

As regulatory affairs professionals, we provide services and deliverables that fulfill our Sponsors' highest expectations and are in compliance with GCP and all applicable federal regulations.