Dohmen has completed the acquisition of a provider of quality assurance and regulatory affairs consulting services, Reglera.
The acquisition will enable Dohmen to integrate Reglera’s consulting services as well as outsource services.
Consulting services include regulatory strategy and submissions, quality systems assessments, compliance remediation, quality system development, design control and process validation, while outsource services include electronic document change control system, complaint handling and adverse event reporting.
Outsource services also include supplier and internal audit programs, managed validation programs, electronic training records management and electronic donor eligibility determination support system.
Dohmen CEO Cynthia LaConte said as personalized medicine becomes an increasingly viable healthcare model, traditional lines between devices, pharma, bio, and tissue begin to blur.
"Expanding our medical device capability became the next logical step in our strategic plan to provide a holistic suite of support services to Life Science companies that are making the transition to therapeutic care companies," LaConte added.
"We acquired Reglera because they share our culture, values and vision — but they also bring significant experience in pre-commercial support services as well as a strong understanding of the tissue and stem cell segment."