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Regulatory Policy Solutions
From the earliest phases of development through manufacturing and distribution, regulatory policy shapes the development, approval, and commercial success of medical products.
ELIQUENT’s Regulatory Policy Solutions are designed to support the needs of businesses as they navigate regulatory policies. Our expert team works cross-functionally to assist pharmaceutical and biotechnology companies, medical device manufacturers, patient groups, trade associations, and other stakeholders in communicating effectively about regulatory policy issues and in understanding, implementing, and complying with new or changing regulations, guidances and legislation.
No matter your pathway, regulatory requirements, or therapeutic market – ELIQUENT’s integrated solutions align with your regulatory goals to unlock excellence.
Strategic & Technical Capabilities
ELIQUENT’s Regulatory Policy Solutions support clients’ participation in regulatory programs and ultimately enhance patient access to innovative medical products. Our regulatory policy team provides advice and recommendations based on their unique blend of institutional knowledge coupled with granular expertise across the product lifecycle.
With an approach that includes both strategic direction and hands-on support, ELIQUENT’s regulatory policy solutions optimize practices to ensure consistency, compliance and operational efficiency. Understanding there is no one-size-fits-all approach, each solution is built to support your regulatory objectives, while aligning with evolving global demands.
Regulatory Policy
Interpretation & Application
ELIQUENT provides unparalleled expertise and strategic insight to organizations navigating emerging regulatory policies and industry trends – ensuring compliance while driving innovation.
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Evaluate existing and emerging regulatory policies to assess their potential impact, including new guidances, regulations and FDA-focused legislation.
Customized policy proposals on targeted topics with supporting campaigns that align with organizational goals and market objectives.
In-depth analysis and interpretation of targeted regulatory topics, including trend analyses, therapeutic landscapes, policy frameworks, and regulatory actions.
Regulatory Advocacy &
Stakeholder Engagement
Engage with stakeholders and shape policy outcomes with targeted advocacy and engagement solutions. Our approach drives impactful results and ensures your voice leads the conversation.
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Shape engagements with regulatory authorities through activities such as commenting on notices and proposed policies and guiding participation in Agency meetings such as workshops, PFDD meetings, and Advisory Committee meetings.
Building effective communication strategies for engaging regulators and stakeholders.
Advise on emerging regulatory policy issues relevant to industry working groups and professional associations.
Regulatory
Policy Intelligence
Stay informed with ELIQUENT’s expert monitoring and analysis of regulatory and market trends. Our expert insights enable smarter decisions and proactive planning for long-term success.
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Proactive monitoring of emerging regulatory developments, including new and updated regulations, guidance documents, notices, and related information; health authority meetings, workshops, and public remarks; market news; and industry trends.
Timely insight and analysis of shifting regulatory policies, market trends, and updates from key regulatory authorities.
Unmatched Expertise
ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to support innovators across the product lifecycle.
With decades of experience, our regulatory policy experts offer a rare blend of perspectives developed as leaders in both the public and private sectors. This wealth of experience equips clients with a trusted partner capable of transforming regulatory challenges into catalysts for innovation and market leadership.
SME Spotlight: Brian Mayhew
A recognized regulatory policy leader, Brian brings more than two decades of experience to his role at ELIQUENT.
Brian’s in-depth understanding of the regulatory landscape is rooted in a diverse career spanning roles across regulated industry and at the U.S. FDA. Brian’s unique blend of professional experience enables a distinct perspective on the interplay between regulators and industry. At ELIQUENT, Brian drives forward-thinking solutions that bridge the gap between regulatory policy and corporate objectives.
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.
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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.
Medical 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.
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Combination Products
Unlock the full potential of your combination product. Our team supports companies developing combination products with expert guidance throughout the product lifecycle.
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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.
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.
Learn MoreGlobal 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+ 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
SOLUTIONS
Regulatory Writing Solutions
Explore ELIQUENT’s Regulatory & Medical Writing Solutions.
Regulatory Writing Solutions
QMSR Solutions
Explore ELIQUENT’s Quality Management System Regulation (QMSR) Solutions.
QMSR SolutionsIQ Central
Shelley Gandhi Joins ELIQUENT + Expanded PV Solutions
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ELIQUENT Experts Co-Author Article Addressing Product Quality & Patient Safety
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ELIQUENT Outcomes: Private Equity Diligence of Multiple Excipient Manufacturing
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