Thank you for visiting our site. In business since 1995, Rocky Mountain Compliance Specialists, Inc. (RMCS) is committed to providing science-based technology and innovation derived quality validation services. RMCS is a leading industry source for validation consulting and contract services. We provide services to the FDA regulated industries (Pharmaceutical, Biopharmaceutical, Medical Device, Diagnostics, Drug Delivery, etc.) and support the following validation related areas:

  • cGMP Facility Design Review Project and Field Management
  • System and Facility Auditing
  • Master Plan Development
  • Factory Acceptance Testing
  • Test Plans
  • Gap Assessment Analysis
  • Technical Writing
  • Control System Validation
  • Installation/Operational Qualifications
  • Performance Qualifications
  • Process Validation
  • Cleaning Validation
  • Sterilization Validation
  • SOP Development
  • and More…

RMCS providing services to FDA regulated industriesServices to FDA regulated industries

We offer a full range of services to FDA regulated companies seeking support in validating manufacturing processes and systems. Our specialties include cleaning and sterilization validation in addition to documentation generation, protocol execution, final reports and the many other aspects associated with companies that are expanding or require complete facility start up manufacturing process support.

RMCS Experience in validationRMCS Experience

RMCS has direct experience with US FDA, European EMEA and Canadian HPB inspections associated with their efforts and leadership. In addition, we have performed facility and vendor audits both in the U.S. and Europe for regulatory compliance. Our chief consultant and owner, Mr. Shane Haft is an active member of the Parenteral Drug Association (PDA) and is a co-author for the first ever PDA published textbook, Cleaning and Cleaning Validation: A Biotechnology Perspective.