Mulcahy Consulting, LLC

About Us

We provide consultative services to clients in the biopharmaceutical research and development industry around the world, supporting the management of all of their TMF needs.

Our Achievements

Uninterrupted 15-year project history providing TMF management consultative services for the smallest to the largest biopharmaceutical research and development companies in the United States and Europe.

Our Vision

Mulcahy Consulting, LLC strives to assist our clients to successfully assess and develop the people and processes that support TMF management, and implement eTMF systems that are easily operationalized and effective; all of which result in TMFs that are inspection-ready on an ongoing basis.  It is that simple.

Our History

Mulcahy Consulting, LLC is a private consulting company based in Western Pennsylvania, USA. It specializes in providing high-quality consultative services with a dedicated focus on the quality and management of Trial Master Files.

Mulcahy Consulting

Our Services

People

People

  • Training on the TMF Management expectations and processes
  • Training of TMF Management and Quality Check personnel
  • (Interim) Lead/Manager of TMF Operations team

Process

Process

  • Creation, Review, Revision, Process Mapping of the TMF management processes:
    – Policies, SOPs, WIs, Manuals, Guides, Forms, etc.
  • SaaS eTMF systems supportive documents
eTMF Systems

eTMF Systems

  • Facilitating RFPs, Selection, and Implementation of new systems
  • Enhancing use of systems already in place
  • UAT Activities – Planning, Script writing, Testing conduct
  • Business Admin capabilities

TMF Management & Quality Review

TMF Management & Quality Review

  • Quality Reviews of active and completed TMFs with observation management
  • Inspection Readiness Strategy and Plan

For all your TMF needs

LET'S TALK TMF

WE ARE ACCEPTING NEW PROJECTS.

Please reach out to us regarding all of your TMF needs.

We are experienced and ready to provide a comprehensive approach to overcome your challenges.

Don’t hesitate to get in touch with Lisa Mulcahy via or email @ lisa.mulcahy@mcllc-tmf.com



Mulcahy Consulting, LLC

Pittsburgh, Pennsylvania 15101 USA
+1-412-522-0788
lisa.mulcahy@mcllc-tmf.com