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.
Strategic & Technical Capabilities
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.
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.
Medical Device Solutions
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.
QMSR Solutions
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.
Regulatory Strategy Development
ELIQUENT collaborates with companies to develop a clear, effective strategy to determine the appropriate regulatory pathway and ensure your LDT meets FDA requirements.
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Comprehensive regulatory strategy roadmap:
Pathway identification (e.g., 510(k), PMA, or de novo)
Identification of classification and submission requirements
Tailored recommendations for expedited FDA approval, where applicable
Pre-Submission Consultation
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.
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From preparing pre-submission materials to supporting you through the full FDA review process, our team ensures that your regulatory submission is precise and complete.
Detailed Pre-Submission (Q-Submission) package preparation
Pre-submission question formulation to optimize feedback
Full support for FDA interactions, including meeting prep and follow-up
Submission Preparation & Support
From initial submission through to approval, ELIQUENT guides innovators in compiling all required documentation, preparing submissions, and ensuring a smooth regulatory review process.
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Strategic & technical direction
Preparation of 510(k), PMA, or de novo submissions
Technical file and supporting documentation development (e.g., device description, labeling, performance data)
Review of predicate devices (if applicable) for 510(k) submissions
Assistance with responses to FDA requests for additional information (AI letters)
QMS Development & Implementation
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.
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Customized solutions:
Comprehensive QMS design, tailored for LDT manufacturing
Procedures for document control, corrective and preventive actions (CAPA), and supplier management
Internal audit plans and audit preparation
Ongoing QMS maintenance and continuous improvement support
FDA Inspection Readiness
ELIQUENT’s regulatory experts develop and implement custom strategies that prepare companies for FDA inspectional responsibilities, while aligning with global regulatory standards and expectations.
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Actionable and proven strategies:
Mock FDA inspections to assess readiness
Detailed inspection response plan development
Post-market reporting, adverse event monitoring, and CAPA implementation
Establishment of product recalls or field actions protocols
Labeling & Marketing Compliance
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.
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Customized solutions:
Review and development of compliant product labeling
Marketing claims validation to align with regulatory submissions
Support for advertising, promotional material reviews, and labeling audits
Clinical Evidence
ELIQUENT supports the generation of clinical evidence needed for regulatory submissions, including clinical study design, data collection, and management.
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Real-world guidance:
Clinical performance study protocols
Data collection and analysis support
Clinical trial oversight and compliance with GCP (Good Clinical Practice) standards
Clinical study report (CSR) preparation for FDA submissions
Supplier Management
ELIQUENT assess, qualifies and provides management for critical suppliers, ensuring they meet regulatory requirements for LDT manufacturing.
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Valuable & objective guidance:
Supplier audits and qualification protocols
Supplier risk assessments
Supplier agreements and quality contracts development
Ongoing supplier performance monitoring
Consultation, Guidance & Training
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.
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Built on the industry’s largest portfolio of quality and regulatory training content and world-class instructional design capabilities, ELIQUENT experts create broad QMSR training solutions across the entire product life cycle that empower teams to elevate regulatory compliance and optimize quality management practices.
Learn more about ELIQUENT’s expert training:Training Solutions >>
QMSR Solutions
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 >>
INFO SHEET: QMRS Solutions >>
Regulatory & Medical Writing Solutions
Experience the power of clarity
From streamlining regulatory approvals to enhancing market presence, our medical writing solutions support your regulatory objectives and strengthen your market position.
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+ 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
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 moreSOLUTIONS
Regulatory Writing
Explore ELIQUENT’s Regulatory & Medical Writing Solutions.
Regulatory Writing Solutions
IQ Central
Single vs. Separate Combination Product Applications
IQ Central
FDA QSR vs. QMSR: What Medical Device Manufacturers Need to Know
IQ Central
ROADMAP: FDA’s New LDT Regulations
IQ Central