Regulatory clarity – from thought to finish
ELIQUENT Life Sciences delivers the answers and solutions global life sciences companies need to gain and maintain market authorization for their products.
We bring clarity to regulatory complexity with integrated regulatory, quality, and safety solutions that clients around the world trust. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.
From concept to commerce and strategy to execution, ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges.
Regulatory Affairs Solutions
PV+ Safety Solutions
Quality & Compliance
Remediation Solutions
Talent Solutions
Unmatched Expertise
ELIQUENT is the singular regulatory resource that that clients around the world trust. 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.
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 across markets and therapeutic 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.
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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
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.