Japan Regulatory Solutions

To ensure success in today’s global life sciences industry, companies must recognize and be prepared for a dynamic regulatory landscape. Guided by decades of regulatory and clinical experience, ELIQUENT Japan partners with innovators to develop a synchronized, global go-to-market approach that unlocks the full potential of the Japanese market.

ELIQUENT’s premier team of globally-minded, bilingual experts have the specialized skills to assist innovators across therapeutic areas, modalities, and markets. Clients turn to ELIQUENT for our deep command of Japan’s regulatory requirements, and our unrivaled ability to partner and communicate with Japan’s local constituencies. This unique blend of strategic guidance and technical skill aligns with your goals to unlock regulatory success. 

Unlock Opportunity

As one of the world’s leading economies, Japan offers life science innovators the unique opportunity to expanded market potential within a supportive regulatory environment. Together with ELIQUENT’s team of regulatory experts, clients leverage the strategic advantages of Japan’s regulatory landscape.

Thriving Pharma Economy

At $95 billion in value, Japan is the third-largest pharmaceutical market in the world, behind only the United States and China. 

Growing Market Demand

An aging society and growing life expectancy, combined with Japan’s population size, drive demand for medical product development.

Regulatory Optimization

Accelerated approval pathways, including the Sakigake Designation Scheme, have helped expedite the regulatory process.

Support for Innovation

The Japanese government actively fosters an environment of innovation by reducing past barriers and creating incentives for life science innovators.

Global Harmonization

Japan’s harmonization with international regulatory standards has simplified the global development process for life science companies.

Enhanced IP Protections

New intellectual property protections benefit life science innovators by safeguarding investments in innovation.

$95 billion

Estimated worth of the Japanese pharmaceutical market

$3.75 billion

Estimated USD value of the Japanese regenerative medicine market


Per capital healthcare spending in Japan – one of the highest among OECD countries

Strategic & Technical Guidance

ELIQUENT Japan guides innovators on their path to approval and beyond. Our team of highly specialized experts provide both strategic direction and hands-on execution services to support clients from the earliest phases of development to post-approval regulatory support.

Development Strategy Planning

Our team of regulatory experts drive efficiency by equipping innovators with valuable insight and actionable strategies that span the product lifecycle and unlock regulatory success.

Application Prep & Submission

ELIQUENT applies extensive regulatory perspective to develop and implement actionable strategies that optimize a product’s regulatory submission and enhance regulatory interactions.

Clinical & Nonclinical Programs

With decades of hands-on experience, ELIQUENT professionals provide best-in-class scientific and regulatory guidance on nonclinical and clinical programs across all therapeutic areas.

Market Entry Planning

Our market entry solutions identify strategies for successful commercialization by considering target patient populations, product positioning, and the competitive environment.

CMC Strategy

ELIQUENT’s highly experienced team of specialists strengthen CMC packages by facilitating risk-based evaluations that enable effective dossiers, manufacturing processes and performance qualifications.

Japan Market Alignment

Experienced and bilingual, ELIQUENT experts support clients with a deep command of Japan’s regulatory requirements, and an unrivaled ability to partner and communicate with Japan’s local constituencies. 

Pathway Decisions & Eligibility

ELIQUENT experts work with companies to develop comprehensive regulatory strategies that take into account special designation eligibility and the pathway selection for a successful result.

Lifecycle Support

ELIQUENT’s team of regulatory professionals bring an unmatched level of credibility and trust when interacting with global regulators and guiding companies on the regulatory pathway.

Regulatory Resources.

Unlock ELIQUENT Excellence.

View or download ELIQUENT Japan’s Regulatory Solutions Information Sheet to explore our integrated service offerings and learn how our team of experts unlocks regulatory excellence.

Info Sheet

View or download ELIQUENT’s Japan Regulatory Solutions Information Sheet to explore our integrated service offerings.

News Release

Unmatched Expertise

ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly throughout the product lifecycle. Together, we create a full-service model that equips clients with a premier regulatory resource.

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

Areas of expertise:

Monoclonal Antibodies

Enzyme Replacement Therapies


Tissue-Based Therapies


Advanced Therapies & CGT

Areas of expertise:

Gene therapy

Somatic cell therapy

Tissue-engineered therapies

Combined advanced therapies

Devices & Diagnostics

Areas of expertise:

Class I, II, and III devices

Digital Health

Molecular Diagnostics


Laboratory Tests

Combination Products

Areas of expertise:

Single-entity, co-packaged, and cross-labeled products

Drug-coated devices

Drug delivery systems

Companion Diagnostics

ELIQUENT Experience

Explore real-world examples of ELIQUENT’s expertise with our case studies. Discover how we’ve helped clients overcome challenges, achieve their goals, and drive tangible results. From innovative strategies to impactful solutions, each case study offers valuable insights into our approach and capabilities.

CASE STUDY: U.S. based pharmaceutical

product strategy for commercialization in Japan

Supporting a U.S. based pharmaceutical company with the development of a product strategy for commercialization in Japan. 


CASE STUDY: Japanese pharmaceutical company

developing product licensed abroad

Supporting a Japanese pharmaceutical company developing a product licensed abroad from PMDA through to complete product approval.


Ready for regulatory clarity? Contact us.