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Laureate Pharma Launches New Regulatory Affairs Services and Appoints Robert G. Burford, Ph.D., as Vice President
Date:11/11/2010

PRINCETON, N.J., Nov. 11, 2010 /PRNewswire/ -- Laureate Pharma, Inc., a full-service biopharmaceutical contract development and manufacturing organization, today announced the establishment of a Regulatory Affairs group and the appointment of Robert G. Burford, Ph.D. FACA as Vice President, Regulatory Affairs.  Dr. Burford will establish and expand regulatory affairs services to support Laureate 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 service offerings will include:  (i) Expert advice regarding preclinical and clinical strategies for development of new drug products; (ii) Expert guidance, preparation and review of electronic regulatory submissions; (iii) Strategies and protocols for implementing process improvements or upgrades for clinical-stage or commercial products; (iv) Comprehensive management and oversight of our client's regulatory affairs needs; (v) Accompanying clients to meetings with regulatory authorities to represent them or to provide impartial expertise; and (vi) Regulatory and quality due diligence for in-licensing opportunities.

"The regulatory process is a critical element of any drug development program," said Robert G. Burford, Laureate's newly appointed Vice President, Regulatory Affairs.  "Laureate's regulatory affairs programs will complement a 30-year track record of successfully developing and manufacturing monoclonal antibodies and other drug products.  We will provide
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SOURCE Laureate Pharma, Inc.
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