Regulatory clarity fromcomplextoclear
Quality & Compliance Solutions
Setting the Standard for Quality & Compliance Excellence.
A strong quality program is a cornerstone of regulatory success. With decades of experience developed as leaders in both the public and private sectors, ELIQUENT is the industry leader in quality and compliance capabilities.
ELIQUENT brings the unmatched expertise that companies need when navigating today’s evolving regulatory environment. Our premier team of regulatory experts have served in senior positions at global regulatory authorities and throughout industry. ELIQUENT’s team of respected professionals, along with a network of ready to deploy global experts, possess the unmatched ability to solve the most technical challenges on a global scale.
Our expert team works across the entire product lifecycle to ensure your processes, systems, and products meet global regulatory requirements and industry best practices. Whether you are developing a new product, optimizing your manufacturing operations, or navigating complex post-market challenges, our team of respected professionals, along with a network of ready to deploy global experts, serve as trusted partners to global life science innovators.
Strategic & Technical Capabilities
ELIQUENT’s unique platform goes beyond traditional consulting to deliver end-to-end solutions. Our integrated quality and compliance services address the entire product lifecycle with best-in-class insight and solutions that bridge the spectrum of regulatory challenges. ELIQUENT full-service quality and compliance solutions align with your regulatory goals to unlock success.
Quality Systems
With decades of hands-on experience, ELIQUENT professionals provide objective evaluation and expert direction on quality system design, optimization, and implementation.
Inspectional Readiness
ELIQUENT applies extensive regulatory perspective to develop and implement custom strategies to prepare companies for inspections and align with regulatory expectations.
Laboratory Controls & Integrity
ELIQUENT experts work with companies to design tailored solutions that equip companies with laboratory controls and data integrity solutions to ensure manufacturing performance.
Compliance & Enforcement Actions
Our team of skilled compliance and enforcement experts provide specialized support and strategic direction when responding to regulatory compliance & enforcement actions.
Supply Chain Optimization
ELIQUENT’s integrated solutions equip life science innovators and manufacturers with strategic insight and actionable strategies to strengthen supply chain management practices.
Good Clinical Practices
Our team of regulatory and quality experts use a risk-based methodology when evaluating clinical quality systems and building sustainable solutions for long-term regulatory success.
Regulatory Meetings & 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.
Consultation, Training & Guidance
ELIQUENT experts provide in-person and remote training services that equip internal teams with the skills to drive continual improvement and help build a common culture of accountability.
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.
-
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.
-
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 >>
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 >>
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.
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.
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
ELIQUENT Experts Co-Author Article Addressing Product Quality & Patient Safety
IQ Central
ELIQUENT Launches Industry Due Diligence Solutions
IQ Central