Laureate Launches Regulatory Affairs Services

Laureate Pharma has established a Regulatory Affairs group and has appointed Robert G. Burford, Ph.D. FACA as vice president of the group. Dr. Burford will establish and expand regulatory affairs services to support clients’ clinical programs.

“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,” said Michael A. Griffith, chief executive officer of Laureate. “We have already initiated our first eCTD project for a new client.”

The new regulatory affairs services will include: advice on preclinical and clinical strategies for drug development, guidance, preparation and review of electronic regulatory submissions, strategies and protocols for implementing process improvements or upgrades for clinical-stage or commercial products, comprehensive management and oversight of regulatory affairs needs, accompanying clients to meetings with regulatory authorities to represent them or to provide impartial expertise, and regulatory and quality due diligence for in-licensing opportunities.

Prior to joining Laureate, Dr. Burford served as president of the American Clinical Research Consultants, Inc., where he provided expert advice and counsel in preclinical toxicology and clinical development of new drug products and medical devices. He is a past president of the Society of Toxicology, Canada, Secretary General of the International Union of Toxicology and is a member of the American Society for Clinical Pharmacology and Therapeutics.