Burford will establish and expand regulatory affairs services to support Laureate clients’ clinical programs.
The new regulatory affairs service offerings will include, expert advice regarding preclinical and clinical strategies for development of new drug products.
It will also include expert guidance, preparation and review of electronic regulatory submissions; strategies and protocols for implementing process improvements or upgrades for clinical-stage or commercial products.
The new group also includes comprehensive management and oversight of the company’s client’s regulatory affairs needs; it also accompany clients to meetings with regulatory authorities to represent them or to provide impartial expertise; and regulatory and quality due diligence for in-licensing opportunities.
Laureate CEO Michael Griffith said that this group will initially focus on the creation and delivery of critical electronic Common Technical Document (eCTD) regulatory submissions for clients as required for global drug product approvals.
"Over time it will expand to provide a full range of regulatory support services including innovative drug and biologic development strategies to achieve our clients’ corporate objectives," Griffith said.