Introducing

ELIQUENT Life Sciences.

The Validant Group of companies have united under a single, cohesive brand: ELIQUENT Life Sciences.

ELIQUENT is the powerful alliance of six global consultancies: Validant, Greenleaf Health, DataRevive, Oriel Stat-a-Matrix, IDEC, and RApport. The collective capabilities of this unmatched alliance enable integrated solutions that bridge the spectrum of regulatory challenges. Together, ELIQUENT Life Sciences sets a new standard for regulatory consulting excellence.

Learn more about our strategic repositioning and how we clear the way to better health.

Regulatory clarity from thought to finish.

ELIQUENT brings clarity to regulatory complexity. We are expert consultants delivering the answers and solutions that life sciences innovators need to gain and maintain market authorization for their products. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to unlock excellence throughout the product lifecycle. We are the convergence of regulatory expertise and technical capabilities across the therapeutic landscape.

Together, ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges. From thought to finish, concept to commerce, and strategy to execution —

ELIQUENT Life Sciences is the singular regulatory resource that clients around the world trust.

Regulatory Affairs

Pharma- covigilance

Quality & Compliance

Remediation Solutions

Training

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

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

Combined Qualifications.
Unmatched Expertise.

ELIQUENT Life Sciences is built on the foundation of five global life science consultancies. Working together as an aligned, coordinated regulatory team, ELIQUENT delivers comprehensive solutions that support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex regulatory landscape.

This unprecedented assembly of regulatory experts enables a unique understanding of the life sciences industry and the unmatched expertise companies need when navigating today’s evolving regulatory environment.

Regulatory Resources.

Unlock ELIQUENT’s Excellence

Explore ELIQUENT’S integrated suite of services and learn how we address the entire product lifecycle with best-in-class insight and and solutions that bridge the spectrum of regulatory challenges.

Together, we unlock regulatory excellence.

View or download resources detailing ELIQUENT’s integrated service offerings:

300+ years of collective FDA experience

Over 160 INDs submitted with a 98% success rate.

Submitted over 50 applications for breakthrough therapies.

News

IQ Central

ELIQUENT LIFE SCIENCES ACQUIRES

EUROPEAN-FOCUSED REGULATORY PARTNER: RApport Global

RApport is a UK based international regulatory consultancy supporting life science innovators gaining and maintaining authorization for products worldwide.  ELIQUENT’s acquisition of RApport represents an important step in company’s international growth and expanded European capabilities.

RApport’s European expertise expands ELIQUENT’s geographic reach and delivers a dynamic portfolio of global regulatory consulting services. The combined capabilities of ELIQUENT and RApport enable end-to-end regulatory solutions designed to streamline development, market entry, and compliance strategies across global markets.

Learn more about this exciting partnership and ELIQUENT’s expanded portfolio of global solutions.

Ready for regulatory clarity? Contact Us.