Redefine regulatory clarity –

thought to finish.

ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges. Our integrated suite of services address the entire product lifecycle with best-in-class insight and valuable guidance. No matter your pathway position, regulatory requirements, or therapeutic market – ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.

Regulatory Affairs

Pipeline Review & Optimization – Skilled evaluation and prioritization to effectively manage regulatory risk

Clinical Programs – Specialized guidance and strategic design of nonclinical, pre-clinical, and clinical programs

CMC Strategy – Risk-based design and effective implementation of phase-appropriate CMC solutions

Pathway Decisions & Eligibility – Expert support on product classifications, special designations, and expedited program pathways

Regulatory Meetings & Communications – Actionable strategies and insight for milestone meetings and regulatory communications

Regulatory Policy Guidance – Customized solutions to understand, implement, and comply with regulatory policies and programs

Marketing, Promotion & Labeling – Strategic direction on labeling requirements, promotional materials, and marketing programs

Lifecycle support – Valuable expertise throughout the product lifecycle, including post-approval requirements and commitments

Pharmacovigilance & Post-Market Surveillance

Global Support – Trusted guidance when navigating and complying with global pharmacovigilance regulations

Adverse Event Reporting – Systematic identification, objective analysis, and strategic guidance responding to unintended occurrences

Regulatory Reporting – Technical skill and institutional knowledge of complex regulatory reporting obligations

Signal Detection – Expert development and implementation of detection processes, including reporting and risk communication

Risk Assessment & Management – Proactive identification, assessment and planning to manage potential risk and ensure regulatory compliance

Post-Marketing Surveillance – Established network experts to support commercial product safety systems and reporting functions

Risk Communication – Strategic development of communications plans to address emerging safety concerns and instill confidence in the market

Clinical Trials Safety Oversight – On-demand resources to support safety monitoring before and after regulatory approval

Quality & Compliance

Quality Systems – Objective evaluation and expert direction on quality system design, optimization & implementation

Inspectional Readiness – Customized strategies to prepare for inspections and align with regulatory expectations

Compliance & Enforcement Actions – Proven expertise when responding to regulatory compliance and enforcement actions

Regulatory Meetings & Communications – Valuable guidance on regulatory communications, meetings, and correspondence

Good clinical practices – Risk-based methodology applied to the design and improvement of clinical quality systems

Laboratory Controls & Data Integrity Systems – Tailored solutions to ensure data integrity and manufacturing excellence

Supply Chain Optimization – Skilled support to evaluate and strengthen supply chain management practices

Consultation, Training and Regulatory guidance – Strategic insight and actionable strategies spanning the product lifecycle

Remediation Solutions

Compliance Assessments – Strategic and technical evaluations to identify areas of non-compliance & mitigate other potential risks

Rapid Response – Immediate deployment of compliance experts to provide valuable on-site support when time is of the essence

Customized Solutions – Actionable remediation plans to correct known problems, prevent future occurrences, and meet regulatory expectations

Corrective Action Plans – Design and enable action plans that are both effective and sustainable for your business

Comprehensive Communications – Valuable direction when interacting with and effectively responding to regulatory communications

Implementation Expertise – Tailored support to implement both acute and systemic improvements across facilities and product lines

On-Demand & On-Site – Skilled resources ready to support implementation plans, sustain compliance, and respond to evolving demands

Third-Party Reporting – Trusted third-party reporting of progress against improvement commitments

Maintenance & Monitoring – Uphold the integrity of implemented practices with ongoing monitoring and maintenance programs


In-person, virtual & on-demand training for teams, private groups, and individuals

Regulatory policies & procedures – Expert instruction on all aspects of regulatory programs across the product lifecycle

Quality Systems – Foundational and in-depth learning programs on quality management systems across the regulatory landscape

Inspectional readiness – Specialized programs to ensure readiness prior to regulatory inspections

Customized training programs – Flexible options to develop training programs on a variety of regulatory subjects

Market Solutions

Guided by decades of experience, spanning all therapeutic areas, ELIQUENT serves as a trusted partner to innovators. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to advise clients on the complex process of bringing new therapies to market and manufacturing them to quality standards. In today’s evolving regulatory environment, ELIQUENT is the proven choice to unlock excellence across therapeutic areas and market landscapes.

Drugs & Biologics

Medical Devices & Diagnostics

Advanced Therapies & CGT

Combination Products

Industry Due Diligence

Pathway Solutions

Pathway solutions to market approval and beyond. Clients turn to our team for objective guidance across the regulatory pathway, to market approval, and beyond. As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. 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 regulatory success.



Regulatory Submissions

Manufacturing & Distribution

Lifecycle Support

Global Solutions

Expertise beyond borders. ELIQUENT’S established and growing global presence spans the regulatory process and major geographic markets. Our premier team of global regulatory experts support clients across the U.S., Europe, and Asia.

Global Solutions

United States




Regulatory Resources.

Unlock ELIQUENT Excellence.

Explore ELIQUENT’S comprehensive capabilities and learn how our team of experts unlocks regulatory excellence. View or download resources detailing ELIQUENT’s integrated service offerings:

Ready for regulatory clarity? Contact us.