MRC|X and Stratum International Merge to Create MRC Global

MRC|X, a Memphis-based regulatory and quality systems consulting firm, has merged with Stratum International, a life sciences consulting firm and wholly-owned subsidiary of Denver-based Pinnacle Healthcare Consulting, to create MRC Global.

The new company will be led by a team of life sciences and medical device industry veterans who have partnered to provide comprehensive solutions in the areas of regulatory, quality, clinical, fair market value and transactional support to medical device, pharmaceutical, biologic and tissue companies within the life sciences community.

MRC Global’s leadership team’s depth of life sciences industry experience includes spinal, orthopedic, trauma and neurological implants and bone void fillers; biologic, tissue and human cellular-based products; medical mobile applications; capital equipment with software (cardiac, infusion imaging, navigation, light and laser-based devices); personal protection equipment (masks, shields, gowns); and dental devices.

The new company will offer a broad range of professional services including global regulatory assessment, planning and strategy; pre-submission, 510(k), Emergency Use Authorization (EUA), Investigational Device Exemption (IDE) Pre-Market Approval (PMA) and de novo preparation and submission to FDA; European technical file and design dossier preparation; FDA, Notified Body, and ISO 13485 audit preparation and participation; Tissues auditing, licensing and registration; and supplier and internal audits, valuation services (company or device), royalty arrangements, co-branding fair market value, and innovative processes to document Key Opinion Leader (KOL) status and payment rate sheet development.

“This partnership with Christine Scifert, Dawn Norman, and the exceptional team at MRC|X is a fantastic opportunity to elevate our services to clients around the world,” said David White, Partner Pinnacle Healthcare Consulting and CEO of Stratum International. “Their expertise, industry reputation and professional integrity is a strong complement to the work Stratum and Pinnacle have developed over the years.”

“We are excited about the next step in our continued growth and look forward to being part of a company with expanding services,” said Christine Scifert, partner with MRC|X. “The partnership and leadership of Pinnacle’s highly successful management team, combined with the depth of our medical device and tissue experience, will lead to more comprehensive support for our clients and continued success.”