Maria Fagan (Regulatory and Quality Solutions LLC (R&G))

Fagan, Maria (Regulatory and Quality Solutions 202009 President + Co-Founder)

	Organisation	Regulatory and Quality Solutions LLC (R&G)
	Group	Regulatory and Quality Solutions (R&G) (Group)
	Product	regulatory services
	Product 2	MedTech (medical technology)

Regulatory and Quality Solutions LLC. (9/16/20). "Press Release: Regulatory and Quality Solutions LLC (R&Q) Acquires Maetrics to Form the Largest Medical Device-Focused Global Regulatory and Quality Consultancy". Monroeville, PA.

Regulatory and Quality Solutions LLC (R&Q)—a leading provider of regulatory and quality consulting services for medical devices, in vitro diagnostic devices (IVDs), and combination products—today announced that it has acquired Maetrics LLC, an international leader in life sciences quality and regulatory consulting. Together, the two organisations form the largest agile and highly scalable consulting firm dedicated to their combined focus areas in the life science industry.

"R&Q’s vision has always been to become the worldwide leader in providing full-service regulatory and quality solutions to the medical device and diagnostic industries,” said the company’s President, Maria Fagan. “Our exceptional business-balanced solutions and leadership have been key to accelerating the success of life science companies and ultimately improving the lives of people across the globe. We’re excited to take a critical step toward achieving our vision by adding Maetrics’ leadership, skills, experience, and global footprint. Together, we will improve even more people’s lives with our highly scalable organisation.”

“We are thrilled to be part of R&Q,” said Maetrics President, Steve Cottrell. “Together, we provide a truly unique consultancy offering to the life science industry. With our combined capabilities, clients know they are working with a leading partner that they can trust to deliver. The healthcare sector is so important to our everyday lives—now more than ever—and both R&Q and Maetrics are dedicated to continually supporting this mission with our effective regulatory and quality solutions.”

Fagan, an original founder of R&Q, claims her favourite quote perfectly describes the integration of R&Q and Maetrics: "The whole is greater than the sum of its parts." (Aristotle) In alignment with this quote, the teams from both companies have rallied around the integration tagline of being “Stronger Together.” As the companies continue to unite, the combined leadership team aims to continue its mission to enhance the lives of patients, clients, and employees. The two companies have found a very natural fit when working on client programmes together. Their similar focus on culture and aligned vision have already created successes for clients and team members alike.

Together, R&Q and Maetrics offer specialist consultancy services to the medical device, diagnostics, and pharmaceutical industries:

> Full-service suite of regulatory and quality solutions, including regulatory strategy and submissions, quality systems, safety risk management, and process validation.

> Expert implementation of complex new regulations, including the EU MDR and IVDR and creation of CERs and PERs, overseen by a former notified body leadership expert on staff.

> Strong clinical practice supporting EU requirements, providing strategies and turnkey approach to completion of CERs, PERs, and PMS-related deliverables (PSUR, SSCP, PMCF/PMPF plans and reports, PMCF/PMPF surveys), led by the former BSI Global Head of Clinical Compliance.

> Strategic regulatory compliance consulting to support businesses at the highest levels, usher in effective compliance strategies, support innovation and growth initiatives, and embed a culture of compliance.

> Regulatory finding response management, providing best practice strategic, tactical, and creative solutions to address NB nonconformity reports, as well as FDA 483 findings, warning letters, and consent decrees, with a highly scalable team for remediation programs.

> Best-in-class project management by certified project managers who are seasoned device professionals focused on RA/QA.

> An international footprint to serve client’s needs, including several offices in the United States and a European headquarters based in Nottingham, England.

For more information on the integrated company, visit https://resources.rqteam.com/raps-convergence-2020-announcement.

About Regulatory and Quality Solutions LLC

Regulatory and Quality Solutions LLC (R&Q) is a leading provider of regulatory and quality consulting and engineering services for medical devices, IVDs, and combination products. Founded by a team of women medical device regulatory experts, R&Q has been providing industry-leading consulting solutions to accelerate the success of life science companies and improve people’s lives since 2008. Its vision is to become a worldwide leader in its market space, achieving significant growth by becoming internationally known for providing exceptional business-balanced leadership that has proven to accelerate the growth of medical device companies and improve people’s lives. For more information, visit RQTeam.com.

About Maetrics LLC

Maetrics is an international leader in life sciences quality and regulatory consulting, focused exclusively on compliance strategies for life sciences companies. Since its founding in 1984, the company has provided insights and experience in the biotech, pharmaceutical, diagnostics, and medical device fields, enabling organizations to achieve compliance while remaining competitive and profitable. By delivering actionable, practical, and realistic strategies designed to fit a client’s needs, Maetrics’ team of industry leaders work in collaboration with our clients to implement business, quality, and compliance solutions. With offices based in the U.S., U.K., and Switzerland, Maetrics offers a global reach to respond whenever and wherever a client needs assistance. For more information, visit Maetrics.com.