Drug & Biological Product Solutions
To ensure success in today’s rapidly evolving biopharmaceutical industry, companies must recognize and be prepared for a dynamic regulatory landscape.
ELIQUENT Life Sciences redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges. Guided by decades of experience, ELIQUENT’s team of experts guides clients through the complete regulatory process, from the earliest stages of product development, through the regulatory review process, to marketing authorization and compliance with postmarket requirements and quality systems. Our integrated suite of solutions aligns with your goals to unlock regulatory success.
Strategic & Technical Capabilities
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.
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.
Pathway Solutions
ELIQUENT guides innovators on their path to approval and beyond.
As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. Our highly specialized experts provide both strategic direction and hands-on execution services to support clients from the earliest phases of development to post-approval regulatory support. ELIQUENT’s pathway solutions include:
Nonclinical Support
ELIQUENT’s customized support guides companies through crucial nonclinical phases with precision and expertise.
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Phase-specific nonclinical support:
- Study design & data analysis, with expertise in toxicology, pharmacokinetics & pharmacodynamics
- Risk management support, including laboratory controls and Good Clinical Practices (GCP)
Preclinical Guidance
Our industry-recognize experts provide valuable insight that aligns with evolving global regulatory demands for long-term success.
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Real-world preclinical guidance:
- Pipeline review & optimization
- Study design & development
- Product classifications
- Expedited pathway guidance
- Regulatory submission support, including dossier writing and application assembly
Clinical Programs
With a proven track record of regulatory success, our team delivers objective guidance and unparalleled support for your complex clinical program.
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Strategic & technical direction:
- Clinical study support, including CRO selection, protocol writing, and biomarker/endpoint selection support
- On-site clinical execution
- Pre-Approval Quality System Compliance Clinical
Regulatory Submissions
ELIQUENT applies extensive regulatory experience to develop a regulatory approach that unlocks the full potential of your product’s journey.
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Valuable & objective guidance:
- Regulatory submission support, including dossier writing and review, and application assembly and submission
- Regulatory meetings and communications
- Pre-approval inspections and response to deficiencies
Post-Approval & Distribution
ELIQUENT evaluates and strengthens systems with an eye toward optimizing processes, mitigating risks, and creating a culture of compliance, while meeting business objectives.
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Customized solutions:
- Quality system design, optimization & implementation
- Good Manufacturing Practices (GMP) Consulting
- Inspectional readiness
- Post-approval commitments
- Marketing, labeling, and promotional practices
Lifecycle Support
Our industry-recognized experts deliver valuable insight throughout the product lifecycle – this approach enables sustained post-market vigilance and a continued market positioning.
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Actionable and proven strategies:
- Regulatory communications and engagement strategies
- Inspectional readiness
- Regulatory policy guidance
- Customized training programs
- Remediation solutions
- Due Diligence & regulatory risk assessments
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+ 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
THOUGHT LEADERSHIP
Impact of R&D Quality Systems & Data Integrity in Drug Development
Read Steven Bowen, Ph.D.’s article in the Journal of Pharmaceutical Sciences.
Read more
Case Study: Global Regulatory Solutions
Learn how ELIQUENT Japan guided a global immunology company to regulatory success.
Read moreSOLUTIONS
Regulatory Writing
Explore ELIQUENT’s Regulatory & Medical Writing Solutions.
Regulatory Writing Solutions
IQ Central
ELIQUENT Expert Co-Authors Journal Article – Impact of R&D Quality Systems & Data Integrity in Drug Development
IQ Central
ELIQUENT Outcomes: Japan Biopharmaceutical Indication
IQ Central
ROADMAP: FDA’s New LDT Regulations
IQ Central