Pharma & Biotech

 CONSULTING – we support you with:

  • Customized Quality Management System (QMS) development, refinement & maintenance
  • Implementation of your QMS
  • Standard Operating Procedure (SOP) documents that are easy to read and follow
  • Proven SOP development and revision methodology that gains buy-in from stakeholders and end users
  • Incorporation of industry best practices into your procedures
  • Integration of existing Quality Management Systems after mergers/acquisitions


ASSESSMENT – we perform:

  • Process analysis and process design
  • Detection of compliance gaps and process inefficiencies – strong expertise in the clinical drug development process


Choosing Mediantis as your partner means we focus on the details while your associates focus on your business. We perform the majority of the work with focused input from all affected functions to ensure regulatory compliance to build a robust QMS.