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Former Vice President, Regulatory Affairs at Abbott Rapid Diagnostics, Joins NDA Partners as Expert Consultant

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Ms. Kiviharju’s leadership experience in regulatory affairs focusing on FDA-regulated molecular and rapid diagnostic products, as well as global regulatory registrations, make her a valuable resource to our clients developing in vitro diagnostic products for the US and international markets.


ROCHELLE, Va. (PRWEB)

NDA Partners President Earle Martin announced today that Leanne Kiviharju, a senior regulatory affairs executive with more than 20 years of experience leading regulatory operations in the in vitro diagnostic industry, has joined the firm as an Expert Consultant. Ms. Kiviharju’s experience focuses on FDA-regulated molecular and rapid diagnostic products, as well as global regulatory registrations in Europe, Canada, Asia, and Australia.

Ms. Kiviharju has held senior leadership roles as Vice President, Regulatory Affairs at Abbott Rapid Diagnostics (formerly Alere, Inc.) and Vice President, Clinical, Regulatory Affairs, and Quality Assurance at Nanogen. She also held senior director roles in regulatory affairs at Illumina and Gen-Probe, where she was responsible for achieving the first FDA authorized next generation sequencing platform and first nucleic acid blood screening assay for HIV-1 and HCV, respectively. Prior to these roles, she was Regulatory Affairs Manager and Quality Assurance Manager at Blood Systems (now Vitalant), a major multi-state blood collection organization regulated by FDA/CBER.

According to Dr. Alberto Gutierrez, Manager of NDA Partners’ diagnostic device development practice, “Ms. Kiviharju’s leadership experience in regulatory affairs focusing on FDA-regulated molecular and rapid diagnostic products, as well as global regulatory registrations, make her a valuable resource to our clients developing in vitro diagnostic products for the US and international markets. We are pleased to welcome her to NDA Partners.”

Ms. Kiviharju received her Bachelor of Laboratory Technology degree in microbiology from the University of Regina in Canada and Medical Laboratory Technology Accreditation (CSMLS) from Pasqua School of Medical Technology in Regina, Canada.

About NDA Partners

NDA Partners, a ProPharma Group company, is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.

Contact

Earle Martin, President

Office: 540-738-2550

MartinEarle@ndapartners.com

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