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.
Quality & Compliance
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
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
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
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.
Validant is a full-service life science consulting firm serving developers and manufacturers of pharmaceuticals, biologics, medical devices, and diagnostics worldwide. Validant provides strategy, execution, and ongoing support for a range of regulatory, compliance, and quality needs.
Greenleaf Health is a leading FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.Explore Greenleaf
DataRevive is a regulatory strategy and consultancy firm that focuses on supporting pharma and biotech to navigate the regulatory approval pathway for global clients in the U.S. market. DataRevive delivers deep real-world regulatory, CMC, preclinical, clinical, and GxP expertise to innovators seeking product approvals in major global markets.Explore DataRevive
IDEC offers regionally specialized regulatory guidance and end-to-end drug product support for pharmaceutical innovators seeking approval in the Japanese market. IDEC assists with both design and implementation of market entry, commercialization, and product management strategies.
Oriel Stat A Matrix (OSAM) is a global leader in training and consulting for business process improvement, regulatory compliance, and quality management systems. Oriel supports life sciences companies’ programs for compliance with FDA and international regulations, prepares product submissions, and makes their processes more effective and efficient.Explore Oriel
RApport is a UK-based international regulatory consultancy supporting life science innovators as they navigate the regulatory landscape. RApport’s team of highly experienced professionals are experts in European regulatory pathways. RApport’s European expertise extends ELIQUENT’s global capabilities and provides our clients with an expanded portfolio of solutions. In addition to our already robust U.S. and Asia Pacific regulatory capabilities, RApport’s specialized skills bring added value to companies gaining and maintaining authorization for products in the European market.Explore RApport
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.
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.