PAREXEL Appoints Three New GMP Consultants for Europe
PAREXEL Consulting (Boston, MA) has hired three senior GMP consultants based in Europe with the hope of helping its clients address complexities of European Union directives in areas such as manufacturing regulations, quality, and safety.
PAREXEL Consulting (Boston, MA) has hired three senior GMP consultants based in Europe with the hope of helping its clients address complexities of European Union directives in areas such as manufacturing regulations, quality, and safety. Clive Brading, formerly with Sanofi-Aventis quality assurance, was appointed director of the PAREXEL European team of experts. Ralf Hess, PhD, who served as chief scientific officer for HISS Diagnostics GmbH, and Siegfried Schmitt, PhD, previously a quality assurance director for Amersham Health, were both appointed principal consultants.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
