CRO Parexel International has acquired all of the outstanding equity securities of privately-owned and UK-based ClinIntel, a provider of clinical Randomization and Trial Supply Management (RTSM) services.
As the EMA has announced that the main objectives of its pharmacovigilance legislation are largely being achieved, the agency is still implementing a number of the individual modules that make up the over-arching law.
The International Society for Pharmaceutical Engineering (ISPE) last week offered up a preview to its plan to help manufacturers avoid or mitigate drug shortages due to manufacturing or quality issues.
ANVISA has set out what it expects of contractors that provide manufacturing, quality control services and drug storage in the Federal Official Gazette of Brazil (DoU) and invited stakeholders to comment.
Regulatory pressure for risk-based supply chain management is increasing excipient suppliers’ audit burden according to the team preparing to launch the 'excipact' certification scheme as an independent association.