Regulatory clarity fromthoughttofinish
Remediation Solutions
Restoring Compliance and Driving Long-Term Success.
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.
Our team of regulatory experts specializes in identifying the root causes of compliance issues and implementing strategic solutions tailored to your specific circumstances. We collaborate closely with your internal teams to develop and execute comprehensive remediation plans that meet the stringent expectations of global regulatory authorities.
ELIQUENT’s team of respected professionals, along with a network of ready to deploy experts, work with companies to investigate, identify, resolve, and prevent both acute and systemic issues at regulated facilities. Together, we equip clients with the informed, objective guidance to detect and solve compliance problems earlier and more effectively.
Strategic & Technical Capabilities
ELIQUENT’s comprehensive suite of remediation solutions is designed to address and resolve compliance issues swiftly and efficiently, ensuring your operations are not only up to standard but also positioned for sustainable success.
From urgent issue resolution to long-term system improvements, our remediation services are crafted to meet the specific needs of your business, ensuring you can focus on growth and innovation while we handle the complexities of compliance.
Guided by decades of experience, ELIQUENT’s team of remediation experts is unmatched. Our highly specialized team provides both strategic direction and hands-on execution services to support clients unique remediation needs.
Compliance Assessments
Our team of experts conduct strategic and technical evaluations to uncover and mitigate areas of non-compliance, enhancing your business’s resilience against regulatory challenges.
Rapid Response
ELIQUENT’s highly experienced team of compliance experts mobilize rapidly to provide essential on-site support, addressing urgent compliance issues swiftly to minimize impact and ensure continuity.
Customized Solutions
ELIQUENT professionals provide tailored remediation plans that effectively address known compliance issues, prevent future problems, and fully align with stringent regulatory standards.
On-Demand, On-Site
Whether you need a team of one or 100+, our skilled on-demand and on-site resources support implementation plans, sustain compliance, and adapt swiftly to evolving business and regulatory demands.
Corrective Action Plans
ELIQUENT experts work with companies to design and implement corrective action plans that are practical and sustainable, seamlessly integrating into your business operations for enduring compliance.
Implementation Expertise
Our team of skilled advisors implement both acute and systemic enhancements across your facilities and product lines, ensuring each modification optimizes compliance and operational efficiency.
Comprehensive Communications
ELIQUENT’s team of respected professionals offer expert guidance on effective communication strategies with regulatory bodies, ensuring your responses and interactions are clear, professional, and compliant.
Maintenance & Monitoring
Maintain the integrity of compliance practices with ELIQUENT’s ongoing monitoring and maintenance solutions. Our team ensures your operations continue to meet evolving regulatory requirements.
Third Party Reporting
ELIQUENT offers trusted third-party reporting services to objectively assess and document your progress in meeting compliance commitments, enhancing transparency and accountability with stakeholders.
Expert Training
ELIQUENT’s customizable training programs equip teams and employees with the tools and skills to maintain regulatory processes and 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.
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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 >>
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 >>
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+ Postmarket 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.
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.
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 Expert Co-Authors Journal Article – Impact of R&D Quality Systems & Data Integrity in Drug Development
IQ Central
Info Sheet: Regulatory & Medical Writing
IQ Central