News Feature | March 4, 2014

Raland Technologies And Compliance Partners, LLC Announce Merger

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By Estel Grace Masangkay

Raland Technologies and Compliance Partners, LLC this week announced their merger resulting in the formation of a new company, Raland Compliance Partners, LLC.

Compliance Partners LLC is a consulting company specializing in FDA regulatory compliance based in Chicago, while Raland Technologies is a regulatory compliance consulting firm based in Fairport, New York. The new company will be based in Fairport while maintaining operations in Chicago, Philadelphia, Cincinnati, and the Washington DC area.

Bill Rader of Raland Technologies, LLC said, "The merger was a natural evolution of our strategic partnership. We’ve worked together as close partners for a number of years. The new Raland Compliance Partners expands the reach and services mix of both companies with very little overlap of our respective customers."

The new Raland Compliance Partners will supply the market with full GxP regulatory compliance solutions. These include helping companies to maintain patient safety through expert consultancy, training, data integrity, and communication from product development to patient delivery. The new firm will also provide expert consultancy and services in pharmaceutical and medical device manufacturing, quality systems, and regulatory affairs. Raland Compliance Partners lists the following areas of expertise:

  • FDA 483 Remediation and Corrective Action Preventative Action (CAPA)
  • Conducting Validity Assessments of BLAs, NDAs and ANDAs
  • Training and Education in GxP (GMP, GLP, GCP)
  • SOPs for Quality Systems including Good Document Practices (GDP)
  • Validation and Quality Assurance Systems Gap Analysis
  • Software Quality Assurance
  • Vendor Qualification (Initial qualification and inspection of suppliers, contract manufacturing, testing laboratories, and software developers)
  • Laboratory Method Development and Validation
  • Laboratory Equipment Validation

Bob Miseyka, Managing Partner of Compliance Partners, said, "Compliance Partners brought to the table a very strong portfolio of clients, and a team of highly regarded professionals. Raland Technologies brings a team of experts in clinical research, pharmaceutical manufacturing, training and communications whose offerings dovetail very well with ours. It's a very exciting combination of expertise, and our customers are responding very positively.”