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CoreMed: Your Trusted Partner in Pharmaceutical Development
CoreMed is a Strategic Regulatory and Drug Development Consulting Firm based in Japan.
CoreMed, a strategic regulatory and drug development consulting firm, was established in Osaka, Japan in March 1998. Since its inception, our primary focus has been on regulatory affairs. We offer practical and strategic support in designing regulatory/development strategies and analyzing the gap between data and regulatory requirements.
We cover all stages of development for pharmaceuticals, biopharmaceuticals, and regenerative medicinal products, covering CMC, nonclinical, and clinical aspects. We closely monitor changes in pharmaceutical legislation and the regulatory environment. At CoreMed, we think globally while understanding local requirements.
Our services include:
- ・Regulatory and development strategy
- ・Consultation meetings with the PMDA
- ・NDA submission
- ・Orphan drug designation application
- ・Responses to inquiries from authorities
- ・Medical/Technical writing (CTD/eCTD, CSR, IB, Study Protocol)
- ・Master File Registration
- ・Foreign Manufacturer Accreditation
- ・Gap analysis
- ・Due diligence
- ・Regulatory intelligence
- ・Project management
- ・National Health Insurance Pricing
- ・Support for legal proceedings (e.g., Expert witness)
At CoreMed, we are dedicated to assisting pharmaceutical companies in developing their products efficiently and expeditiously by guiding them through the regulatory approval process in Japan. Our experts in Regulatory Affairs, CMC, Nonclinical, and Clinical passionately support pharmaceutical companies in launching their products by designing the most suitable development strategy.
We leverage our experience in regulatory and development strategy consulting for new drugs in a wide range of fields, including small molecules, oligo nucleotides, antibody and other biotechnology-based drugs, as well as cell therapy and gene therapy products. We are committed to providing high-quality services to our clients and contributing to people’s health.Corporate Information
- Company name
- CoreMed Corporation
- Foundation
- March 16, 1998
- Our main services
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Regulatory Consulting including but not limited to:
- ・Design, execution and gap analysis of regulatory strategy
- ・Design and planning, evaluation, management and support of clinical development
- ・Design, gap analysis of CMC documents/programs
- ・Design and planning, strategic development and management of nonclinical studies
- ・Preparation and arrangement of Consultation Meetings with PMDA
- ・Writing, preparation, compilation and submission of regulatory applications including CTD/eCTD, Orphan Drug Designation Applications, DMF, FMA, CTNs
- Membership
- Kansai Pharmaceutical Industry Association
- Headquarters
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Tsunenari Bldg., 2-1-21, Kitahama, Chuo-ku, Osaka 541-0041, Japan
(TEL）+81-(0)6-6221-1352 (FAX)+81-(0)6-6221-1357 - Tokyo office
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13F Pacific Century Place Marunouchi, 1-11-1, Marunouchi, Chuo-ku, Tokyo 100-6213, Japan
(TEL) +81-(0)3-6860-8642 (FAX) +81-(0)3-6860-8201 - Management
- Masami Tamura, Pharmacist, President and CEO, Co-founder
- Senior Regulatory Advisor
- Toshiki Hirai, M. Pharm (Former Director of Evaluation and Licensing Division of Pharmaceutical and Food Safety Bureau, MHW)
Business Partners
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- A2 Healthcare Corporation
- A2 Healthcare Corporation is a full-service CRO that provides clinical development solutions for pharmaceuticals and medical devices. They serve as an In-Country Clinical Trial Caretaker (ICCC) for companies who reside outside of Japan. As a strategic partner of CoreMed, we leverage each other’s strengths to provide high-value services from early development to approval.
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- Digital Media System Co., Ltd.
- Digital Media System Co., Ltd. (dms) is a leading company in eCTD in Japan, providing eCTD-related services since the start of eCTD implementation in 2004. As the exclusive distributor of LORENZ DocuBridge in Japan, dms also provides support for meeting Japan-specific specifications, sales and implementation, and maintenance. As a collaboration partner of CoreMed, dms publishes eCTD for CTDs created by CoreMed and we support our clients’ JNDA applications.
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- regulanet®
- regulanet® is a network of independent regulatory affairs consultancies with representation in over 90 countries throughout the world. Founded in 2001 by regenold GmbH, regulanet® offers services to a wide variety of national and international healthcare and pharmaceutical clients. CoreMed collaborates as a partner of regulanet® in Japan.
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- Global Regulatory Affairs Advisors
- GRA Advisors is a network of advisors who have over 25 years of industry experience and offer tailored regulatory strategies. GRA Advisors operates globally, headquartered in the US, and have country-based advisors in China, India, Japan, Korea, and Taiwan. Our regional presence extends through ASEAN, AfME, and LATAM, and includes experts from the WHO, representing regulatory expertise in over 100 countries.CoreMed collaborates with GRA as a Japan expert.
