fromthoughttofinish
Solutions
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
Training
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.
Pre-Clinical
Clinical
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
Europe
Japan
China
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: