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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.
Strategic Storytelling
ELIQUENT understands that the best stories are built through collaboration. Our medical writers partner with your internal teams to build a story that positions your product for success. This collaborative approach captures your product’s journey, prioritizes your business objectives, and builds a compelling narrative that resonates with regulators.
Accelerate Time to Market
Effective medical writing anticipates potential questions or objections from regulators and addresses them within the narrative. By complying with regulatory requirements the first time around, ELIQUENT’s Medical Writing Solutions streamline the approval process, reduce delays, and accelerate your product’s journey from concept to market.
Expand Global Market Entry
Entering global markets involves more than just innovative products – it requires precise, clear, and regulatory-compliant documentation. ELIQUENT’s medical writing team distills complex scientific data into accessible, authoritative documents that meet the regulatory requirements of international regulatory bodies.
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
Read ELIQUENT’s news release announcing ELIQUENT Japan’s new trade name.
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
Biosimilars
Tissue-Based Therapies
Vaccines
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
Immunoassays
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.