Combination Product Solutions


As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. ELIQUENT’s highly specialized combination product experts provide both strategic direction and technical support from the earliest phases of development to post-approval regulatory support.

Our in-depth knowledge and understanding of the global regulatory landscape provides clients with a trusted partner when navigating the complex process of bringing combination products to market.

300+ years of collective FDA experience

Over 160 INDs submitted with a 98% success rate.

Submitted over 50 applications for breakthrough therapies.

As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. ELIQUENT’s highly specialized combination product experts provide both strategic direction and technical support from the earliest phases of development to post-approval regulatory support.

ELIQUENT’s Combination Product Solutions include:

Product Classification

The ELIQUENT team provides strategic and technical guidance to determine a product’s regulatory identity (classification) as a drug, device, biological product, or combination product.

Regulatory Submissions

ELIQUENT applies extensive regulatory perspective to develop and implement strategies that optimize a product’s regulatory submission and agency interactions at every step..

Premarket Pathway

Guided by decades of regulatory experience, ELIQUENT experts provide best-in-class premarket support across all potential pathways, including: NDA, ANDA, BLA, PMA, 510(k), De Novo.

Quality & Manufacturing

ELIQUENT evaluates and strengthens systems with an eye toward optimizing processes, mitigating risks, and creating a culture of compliance, while meeting business objectives.

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.

ELIQUENT’s unique platform goes beyond traditional consulting to deliver full-service support. Our solutions address the entire product lifecycle with best-in-class insight and guidance that bridges the spectrum of regulatory challenges. 

From the earliest phases of development, through regulatory submissions, to post-approval support, ELIQUENT’s robust blend of technical skill and clinical expertise guide companies to approval and beyond.

Regulatory Expertise

Guided by former FDA, EMA, and industry leaders, ELIQUENT collaborates seamlessly to provide the strategic and technical guidance that unlocks excellence throughout the product lifecycle.

Digital Health

ELIQUENT experts provide guidance to clients developing, commercializing, utilizing, and investing in innovative digital health technologies as they navigate the evolving landscape of digital health regulatory requirements.

Quality & Manufacturing

ELIQUENT’s experts build customized solutions that equip companies with best-in-class solutions to ensure their medical devices and combination products are manufactured according to applicable quality standards and regulations.

Combination Products

ELIQUENT experts are a valued partner to sponsors when determining how regulatory agencies will likely regulate their combination products throughout the product lifecycle.

Premarket Pathway & Submissions

Guided by decades of regulatory experience, ELIQUENT experts work with companies to determine the best pathway to market for a product and develop a comprehensive strategy to achieve a successful result.

Marketing & Promotional Practices

ELIQUENT provides companies with regulatory support on product labeling and promotional materials, including direct-to consumer (DTC) promotion on social media and assistance with remediating alleged promotional violations.

Expert Training

ELIQUENT experts create training solutions across the entire product life cycle that empower teams to elevate regulatory compliance and optimize quality management practices.

Medical Device Solutions

Explore ELIQUENT’s Medical Device capabilities:

A strong quality program is a cornerstone of regulatory success. For medical device, in-vitro diagnostic, and combination product manufacturers, realignment to the FDA’s new QMSR is critical to maintain compliance, ensure product quality, and remain competitive in an evolving regulatory landscape. As the industry leader in quality and compliance solutions, ELIQUENT partners with companies to ensure a seamless to the new regulation while maintaining regulatory compliance and product excellence.

ELIQUENT collaborates with companies to develop a clear, effective strategy to determine the appropriate regulatory pathway and ensure your LDT meets FDA requirements.

We assist in preparing pre-submission packages (Pre-Subs) and facilitate meetings with the FDA to obtain feedback on your product, reducing the risk of rejections or delays.

From initial submission through to approval, ELIQUENT guides innovators in compiling all required documentation, preparing submissions, and ensuring a smooth regulatory review process.

ELIQUENT collaborates with companies to establish and maintain a robust QMS that meets FDA’s Quality Management System Regulation (QMSR), ensuring your laboratory is audit-ready and compliant at all times.

ELIQUENT’s regulatory experts develop and implement custom strategies that prepare companies for FDA inspectional responsibilities, while aligning with global regulatory standards and expectations.

Our deep bench of former FDA officials and industry experts ensure your LDT’s labeling and marketing materials comply with FDA regulations and avoid enforcement actions for misbranding.

ELIQUENT supports the generation of clinical evidence needed for regulatory submissions, including clinical study design, data collection, and management.

ELIQUENT assess, qualifies and provides management for critical suppliers, ensuring they meet regulatory requirements for LDT manufacturing. 

Our market leading insight and global solutions equip companies with solutions that reduce the risk of non-compliance while enhancing operational efficiency, product quality, and market access.

As the industry leader in quality and compliance solutions, ELIQUENT partners with companies to ensure a seamless to the new regulation while maintaining regulatory compliance and product excellence. Explore ELIQUENT’s QMSR Solutions:

QMSR 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 >>

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.

Market Solutions

Guided by decades of regulatory and clinical experience, our premier team of life science experts have the specialized skills to assist clients across therapeutic areas, modalities and markets.

Market Solutions

Pathway Solutions

As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. Clients turn to our team for strategic direction and hands-on execution services that support the earliest phases of development to post-approval and beyond.

Pathway Solutions

Global Solutions

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.

Global Solutions

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.

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

INFO SHEET: Medical Device Solutions

Download ELIQUENT’s information sheet.

Info Sheet

INFO SHEET: Regulatory Affairs Solutions

Download ELIQUENT’s information sheet.

Info Sheet

THOUGHT LEADERSHIP

ELIQUENT Insights: Single vs. Separate Combination Product Applications

Read Mark Kramers’s article addressing the strategic and practical considerations of single or separate cross-labeled combination product submissions.

Read more

Container Closure System & Component Changes – Glass Vials & Stoppers

Read ELIQUENT’s summary of the FDA’s recent guidance for industry.

Read more

SOLUTIONS

Regulatory Writing

Explore ELIQUENT’s Regulatory & Medical Writing Solutions.

Regulatory Writing Solutions

QMSR

Explore ELIQUENT’s Quality Management System Regulation (QMSR) Solutions.

QMSR Solutions

Ready for regulatory clarity? Contact us.