Overview

Process optimization is one of the most sought-after business areas. As an organization develops over time, processes become more imprecise. We advise on how to improve processes and support these with clever IT.

HERAX can help optimize and align processes across the organization and geography enabling true global collaboration across R&D eliminating silos and local procedures that has been created over time.

A fast-paced and competitive environment with increasing complexity leads to quick fixes and workarounds with no overall structure, leaving the business with ineffective and repetitive processes.

Key areas:

• Process Analysis, Optimization and Digitalization – Provide process analysis, As-Is, To-Be, GAP analysis, digitalization of processes, and how to optimize them based on our best-in-class experience.
• SOP/WI Development – SOPs are essential to compliance. HERAX offers a full range of services from compliance
  advisory services, revision and development of new SOPs to compliance evaluation in implementation projects.
• Process Framework Development – To be efficient and scalable a good process framework is needed, with simple to understand levels and SOPs. We can develop and optimize your current setup.

We combine our proven Life Science specific project methodology with a “best-in-class” knowledge of the Clinical Development, Regulatory Affairs and Pharmacovigilance business areas and facilitate workshops to plan and conduct workshops.

We use interviews that identify the scope and needs followed by an agile/iterative approach where process flows, SOPs Work Instructions (WI’s) and frameworks will be updated and reviewed. At the end SOPs, WI’s, templates, and framework will be finalized and approved.

Process Analysis, Optimization and Digitalization

With our in-depth knowledge of ways of working in R&D, we can help you assess the current ways of working within one
or more processes areas, explore areas of improvement and suggest how existing or innovative solutions may support
processes better.

SOP activities

SOPs are essential to compliance. We can provide a full range of services from advisory, revision and full development of new SOPs.

Process Framework Development

To be efficient and scalable a good process framework is needed. We will help you develop and optimize your current setup.

Read all key activities and deliverables here.