ELIQUENT

ELIQUENT Life Sciences

ELIQUENT Life Sciences offers comprehensive regulatory, quality, and safety solutions for pharmaceutical, biotech, and medical device companies. They specialize in navigating complex regulatory landscapes, including QMSR transitions and CMC solutions.

ELIQUENT Life Sciences is a premier global consulting group providing integrated regulatory affairs, pharmacovigilance, quality, and compliance solutions. They support pharmaceutical, biotechnology, medical device, and combination product companies across various therapeutic modalities and global markets. With a team of former regulators and industry leaders, ELIQUENT offers unparalleled expertise in guiding clients through the entire product lifecycle, from early development to post-approval support. Their services are designed to bring clarity to regulatory complexity, ensuring clients gain and maintain market authorization. ELIQUENT is particularly adept at assisting companies with critical transitions, such as the FDA's shift from QSR to QMSR for medical device manufacturers. They provide tailored solutions, expert commentary, and resources to ensure a smooth and successful adaptation to new regulatory frameworks. Their CMC solutions and remediation services further support companies in achieving and maintaining compliance. Their foundation is built on experts with extensive strategic and technical skills, offering objective and reliable guidance. ELIQUENT's global presence and network of experts enable them to solve complex technical challenges on a global scale, making them a trusted partner for life science innovators.

About

**Who they are**
ELIQUENT Life Sciences is a provider of regulatory, quality, and safety solutions for the pharmaceutical, biotech, and medical device industries. They focus on helping companies navigate complex regulatory environments.

**Expertise & scope**
* Specializes in the FDA's transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR).
* Offers tailored solutions for medical device, in-vitro diagnostic, and combination product manufacturers adapting to the QMSR framework.
* Provides expertise in CMC solutions, regulatory affairs, quality and compliance, pharmacovigilance, risk management, talent solutions, and remediation solutions.
* Addresses the entire product lifecycle.

**Reputation / proof points**
* Emphasizes a data-driven, risk-based approach aligned with internationally recognized QMS standards.
* Assembles regulatory leaders, industry experts, and technical specialists for collaborative solutions.

Additional information

ELIQUENT supports organizations through critical regulatory transformations, such as the QMSR transition. They offer resources like an information sheet and webinars featuring their experts to help clients understand and prepare for upcoming changes. Their approach emphasizes a smooth and successful adaptation to new regulatory frameworks, aiming for regulatory excellence. They also provide CMC solutions, which may involve detailed documentation and strategic planning for product development and lifecycle management.

Key Highlights

  • Specializes in the FDA's transition from QSR to QMSR for medical device, in-vitro diagnostic, and combination product industries. Source
    “The FDA’s transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks a pivotal shift...”
  • Offers comprehensive regulatory, quality, and safety solutions. Source
    “ELIQUENT Life Sciences offers comprehensive regulatory, quality, and safety solutions for pharmaceutical, biotech, and medical device companies.”
  • Provides tailored solutions through a collaboration of regulatory leaders, industry experts, and technical specialists. Source
    “Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to provide tailored solutions...”

Certifications & Trust Signals

  • Focuses on a data-driven, risk-based approach harmonized with international QMS standards. Source
    “The new streamlined regulation is harmonized with internationally recognized QMS standards and emphasizes a data driven risk-based approach...”

Buyer Snapshot

Best for
  • Medical device, in-vitro diagnostic, and combination product manufacturers
  • Companies needing to transition from QSR to QMSR
How engagement typically works
  • Collaborative approach with regulatory leaders and industry experts
  • Tailored solutions for specific client needs
Typical deliverables
  • QMSR transition strategy and implementation support
  • Regulatory affairs consulting
  • CMC solutions
  • Quality and compliance guidance
Good to know
  • Best when requiring specialized expertise in FDA regulatory transitions.
HQ: United States, US
Languages: English
Timezones: EST, PST
Status: listed

Services & Capabilities

FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)

Jurisdictions: US
Countries: US
Industries: Medical Devices, IVD
Onboarding time: 7–21 days
Pricing model: Custom pricing
Service Types: QMSR/ISO 13485 Gap Assessment, SOP / Documentation Remediation, CAPA & Nonconformance Remediation
Earliest Start: flexible
Delivery Mode: Hybrid
Inspection Experience: Former FDA investigator on team, Supports mock inspections regularly, ISO 13485 lead auditor capability

Additional fda_qmsr_transition_inspection_readiness Details

Service Types
QMSR/ISO 13485 Gap Assessment, SOP/Documentation Remediation, Training & Competency Programs, 483 Response & Remediation Support
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Supports mock inspections regularly
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