ELIQUENT brings clarity to regulatory complexity. We are expert consultants delivering the answers and solutions that life sciences innovators need to gain and maintain market authorization for their products.
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.
Explore SolutionsIntroducing
ELIQUENT Life Sciences
ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.
About ELIQUENT
ELIQUENT is the singular regulatory resource that that clients around the world trust. No matter your pathway position, regulatory requirements, global market or therapeutic area – ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.
Unprecedented Assembly
ELIQUENT’s foundation is built on experts with the foremost strategic and technical skill. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to deliver objective, reliable guidance across the product lifecycle.
Unmatched Expertise
With decades of experience in senior positions at the FDA, EMA and throughout industry, ELIQUENT’s team of respected professionals brings unmatched expertise that companies need when working directly with regulators and navigating today’s evolving regulatory environment.
Full-Service Solutions
Our unique platform goes beyond traditional consulting to deliver full-service solutions that equip clients with a premier regulatory resource. Together, we redefine regulatory consulting with integrated solutions that unlock success and clear the path to better health.
Combined Qualifications.
Unmatched Expertise.
ELIQUENT Life Sciences is built on the foundation of five global life science consultancies. Working together as an aligned, coordinated regulatory team, ELIQUENT delivers comprehensive solutions that support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex regulatory landscape.
This unprecedented assembly of regulatory experts enables a unique understanding of the life sciences industry and the unmatched expertise companies need when navigating today’s evolving regulatory environment.
Full-Service Support
ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to provide a full- service engagement that delivers end-to-end support. No matter your pathway position, regulatory requirements, global market or therapeutic area – ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.
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From the earliest phases of innovation through regulatory submissions, to post- approval support, ELIQUENT’s robust blend of technical skill and clinical expertise guide companies to approval and beyond.
Pipeline Review & Optimization – Skilled evaluation and prioritization to effectively manage regulatory risk
Clinical Programs – Specialized guidance and strategic design of nonclinical, pre-clinical, and clinical programs
CMC Strategy – Risk-based design and effective implementation of phase-appropriate CMC solutions
Pathway Decisions & Eligibility – Expert support on product classifications, special designations, and expedited program pathways
Regulatory Meetings & Communications – Actionable strategies and insight for milestone meetings and regulatory communications
Regulatory Policy Guidance – Customized solutions to understand, implement, and comply with regulatory policies and programs
Marketing, Promotion & Labeling – Strategic direction on labeling requirements, promotional materials, and marketing programs
Lifecycle support – Valuable expertise throughout the product lifecycle, including post-approval requirements and commitments
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With an approach that includes both strategic direction and hands-on global support, ELIQUENT’s customized pharmacovigilance services empower companies to operate with confidence.
Global Support – Trusted guidance when navigating and complying with global pharmacovigilance regulations
Adverse Event Reporting – Systematic identification, objective analysis, and strategic guidance responding to unintended occurrences
Regulatory Reporting – Technical skill and institutional knowledge of complex regulatory reporting obligations
Signal Detection – Expert development and implementation of detection processes, including reporting and risk communication
Risk Assessment & Management – Proactive identification, assessment and planning to manage potential risk and ensure regulatory compliance
Post-Marketing Surveillance – Established network experts to support commercial product safety systems and reporting functions
Risk Communication – Strategic development of communications plans to address emerging safety concerns and instill confidence in the market
Clinical Trials Safety Oversight – On-demand resources to support safety monitoring before and after regulatory approval
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ELIQUENT’s team of highly specialized compliance experts build customized solutions that equip companies with best- in-class strategic support, technical expertise, and project- based solutions.
Quality Systems – Objective evaluation and expert direction on quality system design, optimization & implementation
Inspectional Readiness – Customized strategies to prepare for inspections and align with regulatory expectations
Compliance & Enforcement Actions – Proven expertise when responding to regulatory compliance and enforcement actions
Regulatory Meetings & Communications – Valuable guidance on regulatory communications, meetings, and correspondence
Good clinical practices – Risk-based methodology applied to the design and improvement of clinical quality systems
Laboratory Controls & Data Integrity Systems – Tailored solutions to ensure data integrity and manufacturing excellence
Supply Chain Optimization – Skilled support to evaluate and strengthen supply chain management practices
Consultation, Training and Regulatory guidance – Strategic insight and actionable strategies spanning the product lifecycle
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Our team of respected professionals and global experts bring an unmatched level of credibility and trust when interacting with regulators and guiding companies to remediation solutions.
Compliance Assessments – Strategic and technical evaluations to identify areas of non-compliance & mitigate other potential risks
Rapid Response – Immediate deployment of compliance experts to provide valuable on-site support when time is of the essence
Customized Solutions– Actionable remediation plans to correct known problems, prevent future occurrences, and meet regulatory expectations
Corrective Action Plans – Design and enable action plans that are both effective and sustainable for your business
Comprehensive Communications – Valuable direction when interacting with and effectively responding to regulatory communications
Implementation Expertise – Tailored support to implement both acute and systemic improvements across facilities and product lines
On-Demand & On-Site – Skilled resources ready to support implementation plans, sustain compliance, and respond to evolving demands
Third-Party Reporting – Trusted third-party reporting of progress against improvement commitments
Maintenance & Monitoring – Uphold the integrity of implemented practices with ongoing monitoring and maintenance programs
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Whether you need a team of one or 100+, ELIQUENT’s talent solutions give you the ability to rapidly scale your team to the right size, with the right level of expertise, in the right locations.
Interim Leadership – tailored to the unique needs of the life sciences industry, ELIQUENT’s Interim Leadership Solutions enable organizations to fill temporary leadership gaps with skilled professionals and an eye toward regulatory success.
Project Based Teams – ELIQUENT’s Interim Project Based Teams provide the expertise, leadership, and support needed to successfully execute project-based objectives on time, within budget, and to the highest quality standards.
Contractor Interim Staffing – ELIQUENT’s Contractor Interim Staffing Solutions are designed for organizations addressing immediate staffing needs. Our team of experts bridge skills gaps, manage workload fluctuations, and execute specific project initiatives.
Functional Service Provider (FSP) Outsourcing – ELIQUENT’s Functional Service Provider (FSP) outsourcing solutions provide organizations with custom solutions that deliver specialized expertise, flexible engagement models, and an eye toward meeting your business objectives.
Recruitment Process Outsourcing (RPO) – Life science innovators rely on ELIQUENT’S Recruitment Process Outsourcing (RPO) Solutions for a streamlined recruitment process that attracts top talent and builds high-performing teams capable of driving business success.
Market Solutions
With a robust understanding of global regulatory requirements, ELIQUENT provides tailored solutions that support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex regulatory landscape. Our team of highly qualified experts bring decades of regulatory, quality, safety, and clinical experience across markets and therapeutic specialties.
Global Solutions
Expertise beyond borders. ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.
United States
ELIQUENT is a leading Food & Drug Administration (FDA) regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies.
Our experts have shaped the landscape of FDA regulatory policy and strategy for decades. We bring this unrivaled knowledge and unique insight to our work with clients every day.
Europe
The ELIQUENT team applies their deep and diverse knowledge of European regulations to keep clients in lock-step with evolving global standards. With decades of experience in the European market, our team understands the intricacies of the European Medicines Agency (EMA) and offers tailored solutions to ensure products meet and exceed the needs of our clients.
Asia
ELIQUENT offers regionally specialized solutions for the innovators across Asia. Our comprehensive solutions include expert guidance to innovators seeking approval in Japan, the third-largest pharmaceutical market in the world. Explore ELIQUENT’s solutions for clients in Japan’s life sciences market.
Explore ELIQUENT Japan >>