ELIQUENT Life Sciences
ELIQUENT Life Sciences is a leading global consulting group that provides comprehensive regulatory affairs, pharmacovigilance, quality, and compliance solutions for pharmaceutical, biotechnology, medical device, and combination product companies worldwide. It unites a team of regulatory leaders, industry experts, and technical specialists to deliver integrated, full-service support across the entire product lifecycle, supporting clients in navigating complex global regulations and achieving regulatory success.
Industries
Nr. of Employees
large (251-1000)
ELIQUENT Life Sciences
123 Regulatory Ave, Suite 100, City, Country
Products
IQ Central (resource hub)
Online resource hub providing case studies, articles, white papers, info sheets and tools focused on regulatory, quality and safety topics.
Regulatory Roadmap Podcast
Podcast series featuring former regulatory officials and industry experts discussing agency policy, reorganization and regulatory strategy implications.
MicroLearnings and on-demand training modules
Short-format video lessons and training designed for quick learning on topics such as QMSR transition, LDT regulation and inspection readiness.
IQ Central (resource hub)
Online resource hub providing case studies, articles, white papers, info sheets and tools focused on regulatory, quality and safety topics.
Regulatory Roadmap Podcast
Podcast series featuring former regulatory officials and industry experts discussing agency policy, reorganization and regulatory strategy implications.
MicroLearnings and on-demand training modules
Short-format video lessons and training designed for quick learning on topics such as QMSR transition, LDT regulation and inspection readiness.
Services
Strategic and technical regulatory guidance across product lifecycle including submission strategy, dossier development, meeting preparation and post-approval support.
Global PV operations including adverse event reporting, signal detection, risk management, regulatory reporting and post-marketing safety support.
QMS design, inspectional readiness, laboratory controls and data integrity programs, and regulatory compliance support.
Compliance assessments, corrective action planning, on-site remediation teams and third-party progress reporting for regulatory remediation.
Interim leadership, project-based teams, contractor staffing, FSP outsourcing and recruitment process outsourcing to scale regulatory and quality functions.
Guidance and implementation support for transitioning from legacy QSR to QMSR, microlearning modules and inspection readiness for device and combination-product manufacturers.
Strategic and technical regulatory guidance across product lifecycle including submission strategy, dossier development, meeting preparation and post-approval support.
Global PV operations including adverse event reporting, signal detection, risk management, regulatory reporting and post-marketing safety support.
QMS design, inspectional readiness, laboratory controls and data integrity programs, and regulatory compliance support.
Compliance assessments, corrective action planning, on-site remediation teams and third-party progress reporting for regulatory remediation.
Interim leadership, project-based teams, contractor staffing, FSP outsourcing and recruitment process outsourcing to scale regulatory and quality functions.
Guidance and implementation support for transitioning from legacy QSR to QMSR, microlearning modules and inspection readiness for device and combination-product manufacturers.
Expertise Areas
- Regulatory affairs and submissions
- Pharmacovigilance and safety surveillance
- Quality management systems and QMSR transition
- GMP and manufacturing quality
Key Technologies
- Regulatory submission authoring and dossier assembly tools
- Pharmacovigilance systems and signal-detection methods
- Quality management system (QMS) frameworks and QMSR-aligned processes
- GMP compliance and manufacturing controls
News & Updates
This strategic acquisition expands ELIQUENT’s full-service quality and compliance capabilities and reinforces the firm’s position as a premier provider of end-to-end support for every stage of the product lifecycle.
This acquisition expands ELIQUENT’s pharmacovigilance platform, providing a broader range of solutions.
Celia Witten, M.D., Ph.D., former Deputy Director of the FDA’s Center for Biologics, joins the ELIQUENT team to support innovators developing advanced therapies.
An article outlining key steps in developing an effective regulatory strategy.
An analysis of Japan’s pharmaceutical market performance in 2024.
Submitted over 50 applications for breakthrough therapies
ELIQUENT has submitted over 50 applications for breakthrough therapies, demonstrating its expertise in advancing innovative products.
This strategic acquisition expands ELIQUENT’s full-service quality and compliance capabilities and reinforces the firm’s position as a premier provider of end-to-end support for every stage of the product lifecycle.
This acquisition expands ELIQUENT’s pharmacovigilance platform, providing a broader range of solutions.
Celia Witten, M.D., Ph.D., former Deputy Director of the FDA’s Center for Biologics, joins the ELIQUENT team to support innovators developing advanced therapies.
An article outlining key steps in developing an effective regulatory strategy.
An analysis of Japan’s pharmaceutical market performance in 2024.
Submitted over 50 applications for breakthrough therapies
ELIQUENT has submitted over 50 applications for breakthrough therapies, demonstrating its expertise in advancing innovative products.