Detail 1

We can assist you in ensuring the quality of your biologics/biosimilar during its entire lifecycle. From pre-market to post-market reviews, inspection, and compliance, we can shepherd your biologics through design, labeling, promotion, production, and testing.

 BIOLOGICS/BIOSIMILAR

Detail 2

1- Invest in an Enterprise Quality Management System (eQMS) that can help you track quality across your entire supply, production, and distribution chain.

2- Establish a Corrective and Preventive Action (CAPA) system to support self-correcting quality systems within your organization and assure that quality issues are resolved.

Detail 3

– Introduction: Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement – Change Management (3.2.3): Innovation, continual improvement, the outputs of process performance and product quality monitoring, and CAPA drive change.