Blog Home TAG: FDA Premarket Approval (PMA)

China Addresses Life Sciences Regulatory Compliance Concerns

China has often faced criticism for lax regulation of drug and medical device manufacturing. In addition, long-term accusations of bribery for inspection favoritism is still a real concern.  Do [...]


FDA States Clear cGMP Expectations for Combination Products

The Food and Drug Administration (FDA) recently released a final guidance on Current Good Manufacturing Practice (cGMP) Requirements for Combination Products. This guidance provides clarification [...]

Turnkey Quality + Compliance Management
IN ONE VERSATILE SYSTEMManage all quality and compliance activities, control risk and streamline workflow with a single easy platform.
Don’t Miss A Post

Subscribe to our blog to receive an email when we publish new content.

Quality Management Software
AssurX Quality + ComplianceA single versatile software system can improve quality, compliance and streamline workflow.