About Us


For over 20 years, our clients have utilized Malcom's experienced professionals and sustainable solutions for preventive measures, remediation, pre-approval inspections, in response to audit observations and to improve overall quality and .

is known as the proven expert in the area of review and simplification, process improvement, and redesign solutions for the Life Sciences industry.

We provide a solid cost effective solution to;

  • Reduce human errors
  • Improve workflows
  • Improve regulatory compliance
  • Reduce redundancies
  • Reduce non-conformances
  • Reduce process risk
  • Reduce time and costs with Implementation
  • Utilizing and implementing industry "best practices"

We develop a realistic, understandable battle plan to tackle and resolve the issues on-time and on-budget.

What We Do-Diagram

This is our reputation in the industry and why clients continue to trust us with their Business Process Management and improvement.

Batch Records

"Over 75% of our clients tried to improve their documentation internally, but lacked a proven approach, methodology, and resources for documentation redesign and implementation."