News
ELIQUENT Announces Global Regulatory Writing Solutions
ELIQUENT Life Sciences, a global regulatory consulting firm, today announced the firm’s global Regulatory and Medical Writing Solutions.
A trusted partner to life science innovators, ELIQUENT’s Regulatory Writing Solutions leverage the unmatched experience and robust institutional knowledge of the firm’s regulatory experts to empower decisions and drive value.
Regulatory Writing Solutions
Regulatory and medical writing plays a crucial role in translating scientific data and clinical findings into clear, compliant, and impactful documents. ELIQUENT’s highly specialized medical writing team unlocks the full potential of life science products by creating a compelling narrative that resonates with regulators and positions products for success. From streamlining regulatory approvals to enhancing market presence, ELIQUENT’s medical writing solutions support regulatory objectives and strengthen market position.
ELIQUENT’s Regulatory Writing Solutions are more than compiling and presenting data – ELIQUENT’s expert team collaborates with innovators and a team of regulatory experts to build compelling stories that guide regulators through an evidence-based narrative. The outcome is a persuasive justification that conveys facts and ultimately supports market entry. ELIQUENT support innovators in the following areas:
Regulatory Documentation
ELIQUENT’s regulatory documentation solutions are tailored to meet the stringent requirements of regulatory authorities worldwide. ELIQUENT collaborates with internal teams to develop scientifically rigorous, accurate documents that are aligned with current regulatory expectations. ELIQUENT’s regulatory documentation solutions include:
- Clinical Development Plans
- Clinical & Nonclinical Common Technical Documents (CTD)
- Clinical Study Reports (CSRs)
- Health Authority briefing documents and responses
- Product Labeling and Instructions for Use (IFUs)
- Protocols
- Pediatric Investigation Plans (PIPs) and Pediatric Study Plans (PSPs)
Safety & Pharmacovigilance
ELIQUENT’s pharmacovigilance writing services ensure safety documentation is not only compliant but also strategically aligned to support the long-term safety and efficacy of products. ELIQUENT’s team collaborates to develop a wide range of pharmacovigilance documents, including:
- Risk Management Plans (RMPs)
- Pharmacovigilance System Master File (PSMF)
- Signal Detection Reports
- Development Safety Update Reports (DSURs)
- Post authorization safety/efficacy studies
- Post-Market Safety Reports
- Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs)
Comprehensive Capabilities
ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges. ELIQUENT’s unique platform goes beyond traditional consulting to deliver end-to-end solutions.
Pathway Solutions
ELIQUENT guides innovators on their path to approval and beyond. As former regulators and industry leaders, ELIQUENT’s understanding of the complete product lifecycle is unrivaled. ELIQUENT’s Medical Writing Solutions align with products development pathways – from initial drafts to final submissions, ELIQUENT provides end-to-end support throughout the regulatory pathway.
Global Solutions
ELIQUENT understands the unique challenges of navigating global regulatory requirements. ELIQUENT’s team of global experts work seamlessly with the firm’s medical and regulatory writing teams to leverage decades of combined global regulatory experience across the U.S., Europe, and Asia Pacific. Whether navigating complex U.S. Food and Drug Administration (FDA) submissions, European Medicines Agency (EMA) clinical trial applications, or preparing for a pre-consultation meeting with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), ELIQUENT’s medical writing solutions are customized to meet each company’s unique regulatory needs.
Market Solutions
ELIQUENT experts demonstrate unequaled levels of skill in their regulatory specialties. ELIQUENT’s team of professional medical writers – working cross-functionally with the firm’s regulatory experts – brings a deep understanding of the pharmaceutical, biotechnology, and medical device industries. With extensive experience across therapeutic areas, ELIQUENT’s writers know how to communicate complex information effectively.
About ELIQUENT Life Sciences
ELIQUENT Life Sciences is the fusion of six global regulatory consultancies: Validant, Greenleaf Health, DataRevive, Oriel Stat-a-Matrix, RApport Global, and IDEC. ELIQUENT team works cross-functionally to deliver the global solutions that pharmaceutical, biotechnology, and medical device companies need to gain and maintain authorization for the products. ELIQUENT’s comprehensive services support innovators across therapeutic modalities, phase-based pathways, and major global markets. ELIQUENT’s continued growth is supported by GHO Capital, the European specialist investor in healthcare. Learn more about ELIQUENT Life Sciences at eliquent.com.