Regulatory Affairs Support Services

Align CRO’s Regulatory Affairs team has the experience and resources to assist with a wide range of regulatory affairs encountered in preparation and throughout the conduct of each clinical trial. Our experience includes, but is not limited to:

• Liaison with local regulatory authorities, Institutional Review Boards, and Ethics Committees

• Creation, preparation, execution, and maintenance of regulatory documents for submission to industry sponsors, ethics committees, and regulatory authorities

• Coordinating and preparing pre-IND packages, INDs, breakthrough applications, and compassionate use submissions