June 20, 2024

ELIQUENT Life Sciences (ELIQUENT), a global regulatory consulting firm for the life sciences industry, today announced that the company’s Japan-based legacy business unit, IDEC, has changed its trade name to “ELIQUENT Japan.” Today’s announcement follows the January 2024 strategic repositioning that united the Validant Group of companies as one global regulatory brand: ELIQUENT Life Sciences.

ABOUT ELIQUENT JAPAN

Guided by decades of regulatory and clinical experience, ELIQUENT Japan partners with drug and device innovators to develop synchronized, global go-to-market approaches that unlock the full potential of the Japanese market.

As one of the world’s leading economies, Japan offers life science organizations the unique opportunity to expand their market potential within a supportive regulatory environment. ELIQUENT Japan’s premier team of globally minded, bilingual experts brings medical products to market by supporting clients with a deep command of Japan’s regulatory requirements, and an unrivaled ability to partner and communicate with Japan’s local constituencies. 

FULL-SERVICE SUPPORT

From the earliest phases of development to post-approval regulatory support, ELIQUENT Japan’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to offer the following regulatory solutions:

Clinical & Nonclinical Programs: Best-in-class scientific and regulatory guidance on nonclinical and clinical programs across all therapeutic areas.

CMC Strategy: Risk-based evaluations that strengthen CMC packages, and enable effective dossiers, manufacturing processes, and performance qualifications.

Pathway Decisions & Eligibility: Comprehensive regulatory strategies that consider special designation eligibility and the pathway selection for a successful result.

Application Preparation & Submission: Actionable strategies that optimize a product’s regulatory submission and enhance regulatory interactions.

Market Entry Planning: Strategic solutions for successful commercialization that incorporate target patient populations, product positioning, and the competitive environment.

Japan Market Alignment: Experienced and bilingual support that facilitates collaboration and alignment between Japan and global innovators.

Lifecycle Support: Strategic direction and hands-on execution services that support clients throughout the product lifecycle.

UNMATCHED EXPERTISE

ELIQUENT Japan works in collaboration with ELIQUENT’s global team of regulatory professionals. Together, ELIQUENT delivers strategic and technical insights that support pharmaceutical, biotechnology, medical device, and combination product companies and investors.

Areas of expertise include:

Drugs & Biological Products: Guidance on drugs and biologics including monoclonal antibodies; enzyme replacement therapies; biosimilars; tissue-based therapies; and vaccines.

Advanced Therapies & CGT: Specialized skill set to move autologous or allogeneic therapies through the regulatory process, including gene therapy; somatic cell therapy; tissue-engineered therapies; and combined advanced therapies.

Devices & Diagnostics: Extensive technical skill and robust institutional knowledge when bringing new devices and diagnostics to market, including Class I, II, and III devices; digital health; molecular diagnostics; immunoassays; laboratory tests; and companion diagnostics.

Combination Products: Support for companies developing combination products, including expertise in single-entity, co-packaged, and cross-labeled products; drug-coated devices; drug delivery systems; and companion diagnostics.

ABOUT ELIQUENT

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 Japan’s regulatory solutions.