All Molclone commercial API packing and certificates of analysis will contain a special Hologram starting in June, 2021. Products or certificates of analysis without Holograms are not considered to be authentic. Please contact us with any verification requests: info@molclonelabs.com

QA & RA

Quality

Molclone adheres and operates within a QA system integrating research, manufacturing and business practices. Some of the core elements include:

  • ICH-GMP, EU-GMP and US cGMP standard
  • Continuous training of all employees
  • Corporate transparency
  • Sustainability and environmental protection
  • Implementation of preventive practices at all levels
  • Empowerment of employees

Regulatory Affairs

Molclone Labs has a long track record in regulatory fillings globally in ICH-regulated territories and other regions. Our Regulatory affairs capabilities encompass the following elements:

  • Regulatory affairs expert as part of Molclone’s corporate team
  • Regulatory affairs advisor, who asses or regular frequency Molclone’s operations and documentation in reference of changing ICH-, EU- and US- regulations
  • US and European regulatory affairs consultant being assigned to specific regulatory affairs projects or submission initiatives