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Oriel STAT A MATRIX
Business Consulting and Services
Washington, DC 9,125 followers
ELIQUENT Life Sciences
About us
Oriel STAT-A-MATRIX has joined forces with our Validant Group partners to reposition as one global regulatory brand: ELIQUENT Life Sciences. The fusion of five global regulatory consultancies, ELIQUENT Life Sciences is built on the foundation of five global life science consultancies: Validant, Greenleaf Health, DataRevive, Oriel Stat-A-Matrix, and IDEC. ELIQUENT Life Sciences creates an unprecedented assembly of regulatory leaders, industry experts, and technical specialists - brought together to bridge the spectrum of regulatory challenges across the product lifecycle. The collective capabilities of the united ELIQUENT team enable a comprehensive approach that delivers integrated solutions to support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex regulatory landscape. From thought to finish, concept to commerce, and strategy to execution— ELIQUENT Life Sciences is the singular regulatory resource that clients around the world trust. LEARN MORE about our strategic repositioning and integrated service offerings at eliquent.com
- Website
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http://www.orielstat.com/
External link for Oriel STAT A MATRIX
- Industry
- Business Consulting and Services
- Company size
- 11-50 employees
- Headquarters
- Washington, DC
- Type
- Privately Held
- Founded
- 1968
- Specialties
- 510(k) and PMA submissions, Process Validation, Curriculum Development and RA/QA Training, CAPA, EU MDR, EU IVDR, MDSAP, Quality System Audits, SaMD, Non-product Software Validation, Clinical Evaluation Report, ISO 14971 Risk Management, Performance Evaluation Report, IEC 62304 Software Validation, Medical Device and Pharmaceutical Training, FDA and EU Regulatory Strategy Development, ISO 13485, 9001, MDSAP, FDA QSR Quality System Implementation, ISO 27001 Cybersecurity Audit and Implementation, RA/QA Staff Augmentation, and Data Integrity (21 CFR Part 11)
Locations
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Primary
Get directions
1055 Thomas Jefferson St. NW
Suite 304
Washington, DC 20007, US
Employees at Oriel STAT A MATRIX
Updates
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Oriel STAT A MATRIX reposted this
ELIQUENT will be at BIO Asia-Taiwan (July 25-28). Meet the team at booth #M928 - or schedule a meeting via the link: https://lnkd.in/ednBz4DK
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Oriel STAT A MATRIX reposted this
Japan's domestic pharmaceutical market reached a record-breaking high of 11.3 trillion yen in 2023. As one of the world’s leading economies, Japan offers life science organizations the unique opportunity to expand their market potential within a supportive regulatory environment. Read Eliquent Japan, Inc Japan's blog post examining the unprecedented growth of this thriving market and learn how our team brings value to life science innovators entering the Japanese market. https://lnkd.in/eP356v-f
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Oriel STAT A MATRIX reposted this
ELIQUENT Expert, Michele Dougherty, examines the FDA's recent update to a draft guidance addressing studies supporting a biological product's interchangeability with reference products. Read Michele's analysis at https://lnkd.in/egv85Ezj
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Oriel STAT A MATRIX reposted this
ELIQUENT welcomes Shaun Stapleton to the team - Shaun is a senior regulatory affairs and drug development professional with extensive international experience in the pharma, biotech and consulting environments. Learn more about Sean at https://lnkd.in/eVYVD7ri
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Oriel STAT A MATRIX reposted this
Members of the ELIQUENT team will be at the annual BIO International Meeting next week in San Diego. Schedule on-site meetings with the team by following the QR codes in our post or via these links: Global Regulatory Affairs: https://qrco.de/bf6WZ2; Japan Regulatory Affairs: https://qrco.de/bf6WTq; and Quality & Compliance: https://qrco.de/bf6WaI. Learn more about ELIQUENT’s comprehensive capabilities at ELIQUENT.com
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Oriel STAT A MATRIX reposted this
ELIQUENT Expert - Ziqi Zhang - addresses the pivotal role IND maintenance plays in clinical trials. Read Ziqi's white paper examining the impact on patient safety and data integrity at ELIQUENT.com https://lnkd.in/epmjSrus
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Oriel STAT A MATRIX reposted this
Members of the ELIQUENT team - Christine Scheve, MSBME, Heidi H., Mikio Ishizawa, and Igor Ilievski MD MBA - will be in San Diego the week of June 3rd for the annual Biotechnology Innovation Organization International Convention. Schedule a meeting with the team via [email protected]
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Oriel STAT A MATRIX reposted this
ELIQUENT Expert, Maura Norden, will join Heather Pearson and Danielle Sloane of Bass, Berry & Sims, for a webinar on May 22nd addressing FDA's final rule outlining the regulation of laboratory-developed tests (LDTs). To register for the webinar, visit https://lnkd.in/e8bME7Pg and to learn more about ELIQUENT’s LDT capabilities, visit eliquent.com
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Oriel STAT A MATRIX reposted this
ELIQUENT Expert - Chris Leptak, MD, PhD - will be on faculty for a course addressing biomarkers in clinical studies at the Annual Scientific Meeting for the American Spinal Injury Association (ASIA).
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