Regulatory clarity fromthoughttofinish
Regulatory Affairs Solutions
To approval and beyond.
In the complex life sciences landscape, where innovation meets regulation, a trusted regulatory partner is paramount.
ELIQUENT is the singular regulatory resource that clients around the world trust. Our unique platform goes beyond traditional consulting to deliver end-to-end solutions. ELIQUENT is more than a service provider—we are your strategic partner in regulatory success.
With a deep understanding of the regulatory landscape, we work as an extension of your team, offering proactive solutions that streamline your path to approval and beyond. Our premier team of regulatory experts have served in senior positions at global regulatory authorities and throughout industry. This rare blend of perspectives developed as leaders in both the public and private sectors enables us to deliver valuable insight throughout the product lifecycle.
No matter your pathway position, regulatory requirements, global market, or therapeutic area – ELIQUENT’s integrated solutions align with your regulatory goals to unlock success.
Strategic & Technical Capabilities
Guided by decades of regulatory and clinical experience, and firmly grounded in the principles of public health, ELIQUENT’s team of regulatory experts is unmatched.
Clients count on us to provide objective advice and valuable insight throughout the product lifecycle. As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. ELIQUENT’s highly specialized experts provide both strategic direction and hands-on execution services to support clients from the earliest phases of development to post-approval regulatory support.
Pipeline Review & Optimization
Our team of regulatory experts evaluate and prioritize development pipelines to identify valuable portfolio opportunities and to understand and effectively manage regulatory risks.
CMC Strategy
ELIQUENT’s highly experienced team of specialists strengthen CMC packages by facilitating risk-based evaluations that enable effective design and implementation strategies.
Clinical Programs
With decades of hands-on experience, ELIQUENT professionals provide best-in-class scientific and regulatory guidance on nonclinical, pre-clinical, and clinical programs across all therapeutic areas.
Regulatory Submissions
ELIQUENT applies extensive regulatory perspective to develop and implement actionable strategies that optimize a product’s regulatory submission and enhance agency interactions.
Pathway Solutions
ELIQUENT experts work with companies to develop comprehensive regulatory strategies that take into account special designation eligibility and the pathway selection for a successful result.
Marketing, Promotion & Labeling
Our team of skilled advisors provide specialized support and strategic direction on labeling requirements, promotional materials, and marketing programs.
Regulatory Communications
ELIQUENT’s team of respected professionals bring an unmatched level of credibility and trust when interacting with global regulators and guiding companies on the regulatory pathway.
Lifecycle Support
ELIQUENT’s integrated solutions equip innovators with strategic insight and actionable strategies that span the product lifecycle and unlock regulatory success.
Unmatched Expertise
Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists set the standard for regulatory consulting excellence. 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 the regulators and when navigating today’s evolving regulatory environment.
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 in the following markets specialties:
Drugs & Biological Products
ELIQUENT’s team of experts provide strategic and technical guidance on drugs and biologics from product development to regulatory review and beyond post-market requirements.
Advanced Therapies & CGTs
Our team of regulatory and clinical experts apply their specialized skill set to move complex therapies through the regulatory process to manufacturing and beyond.
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Areas of Expertise:
Monoclonal Antibodies
Enzyme Replacement Therapies
Biosimilars
Tissue-Based Therapies
Vaccines
Combination Products
Unlock the full potential of your combination product. Our team supports companies developing combination products with expert guidance throughout the product lifecycle.
Devices & Diagnostics
Leverage our team’s extensive experience as you navigate the process of bringing new devices and diagnostics to market and manufacturing them to quality standards.
Industry Due Diligence
ELIQUENT applies vast institutional knowledge to equip investors with the information needed to ensure life science transactions account for business objectives, regulatory risks, and the industry landscape.
Cosmetics
ELIQUENT’s knowledge and understanding of the evolving cosmetics regulatory landscape provides clients with a trusted partner when developing and commercializing cosmetic products in compliance with regulations.
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Areas of Expertise:
Product labeling & claims
MoCRA Requirements
Compliance service offerings
Regulatory policy solutions
Expert training
Learn more about ELIQUENT’s Cosmetics Solutions:
INFO SHEET: Cosmetics Regulatory Solutions >>
Focus Areas
ELIQUENT’s foundation is built on experts with the foremost strategic and technical skill across markets, pathways, and global regulations. ELIQUENT’s specialized solutions showcase our collective capabilities and combined expertise. Together, we create a full-service model that equips clients with a premier regulatory resource.
QMSR Solutions
The FDA’s transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks a pivotal shift for the medical device, in-vitro diagnostic, and combination product industry.
The migration to QMSR will have far-reaching impact on how medical device manufacturers approach quality management systems. ELIQUENT Life Sciences is uniquely positioned to support organizations during this critical transformation.
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 >>
Integrated Solutions.
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.
Regulatory Affairs Solutions
PV+ Post Market Surveillance
Quality & Compliance
Remediation Solutions
Talent Solutions
From the earliest phases of innovation through regulatory submissions, to post- approval support, our robust blend of technical skill and clinical expertise guide companies to approval and beyond.
With an approach that includes both strategic direction and hands-on global support, ELIQUENT’s customized pharmacovigilance solutions empower companies to operate with confidence.
Our team of highly specialized quality & compliance experts build customized solutions that equip companies with best-in-class strategic support, technical expertise, and project-based solutions.
ELIQUENT’s Remediation Solutions address challenges head-on, providing the expert guidance life science innovators need to bring your operations back into compliance and securing your path forward.
Whether you need a team of one or 100+, ELIQUENT’s talent solutions gives you the ability to rapidly scale your team to the right size, with the right level of expertise, in the right locations.
Your resource for regulatory clarity.
IQ Central is your resource for industry insights, expert perspectives, and valuable tools. Here, you’ll find a comprehensive collection of collateral, expert resources, and thought leadership designed to support your goals and keep you informed on the latest trends and help you navigate today’s regulatory landscape.
Resources
THOUGHT LEADERSHIP
Quality Systems in Drug Development
Read Steven Bowen, Ph.D.’s article in the Journal of Pharmaceutical Sciences.
Read more
Case Study: ELIQUENT Outcomes
Global regulatory strategy for immunology company to regulatory success.
SOLUTIONS
Pharmacovigilance & Risk Management Solutions
Explore ELIQUENT’s PV & Risk Management Solutions
Pharmacovigilance & Risk Management
QMSR Solutions
Explore ELIQUENT’s Quality Management System Regulation (QMSR) Solutions.
QMSR SolutionsIQ Central
Shelley Gandhi Joins ELIQUENT + Expanded PV Solutions
IQ Central
Container Closure System & Component Changes – Glass Vials & Stoppers
IQ Central
ELIQUENT Expert Co-Authors Journal Article – Impact of R&D Quality Systems & Data Integrity in Drug Development
IQ Central