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CoreMed: Delivering Meticulous Services for Pharmaceutical Development
CoreMed, a Strategic Regulatory and Drug Development Consulting Firm, is your trusted partner in navigating the complex world of pharmaceutical development. We offer comprehensive support for all development and regulatory-related tasks such as establishing development strategies, PMDA consultation, JNDA filing strategy, writing application documents (CTD M1-M5/eCTD), GMP inspection, Compliance inspection and various regulatory submissions (Orphan Drug Designation, DMF, Foreign Manufacturer Accreditation, Variations, Partial Change Approval). Our expertise extends to CMC, non-clinical, and clinical strategies, ensuring a seamless journey from development to approval.
Since our inception in 1998, we have steadfastly upheld our ‘Quality First’ principle, delivering meticulous services that align closely with the needs of our clients. Our extensive knowledge spans a wide range of disease areas and modalities, enabling us to support pharmaceutical development for a diverse range of clients, from start-ups to mega-pharmaceutical companies, both domestically and internationally.
Leveraging our wealth of experience, we are committed to meeting the unique needs of our clients. We don’t just provide services, we build partnerships, working hand-in-hand with our clients to bring life-changing treatments to those who need them most. Trust CoreMed to guide you through the intricate landscape of pharmaceutical development, where quality, expertise, and dedication pave the way to success.
Our Services
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- Regulatory & Development Strategy
- Our consultants, who are experts in the latest medical, pharmaceutical, and regulatory affairs both in Japan and globally, propose the best regulatory and development strategy. This strategy ensures a reliable and quick regulatory pathway to your goal, while maintaining alignment with your basic strategy.
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- PMDA Consultation
- We establish the best strategy for PMDA consultations, tailored to client’s needs taking into account the regulatory status in other countries. Our team evaluates and prepares documents, and handles procedures and negotiations with the authorities.
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- CTD & Regulatory Document Writing
- Our consultants, who are up-to-date with the latest regulatory requirements and have extensive approval application experience, evaluate and write various regulatory-related documents, including CTD. We handle all CTD modules, including regulatory (M1) , CMC (M2.3 and M3), non-clinical (M2.4, M2.6, and M4), and clinical modules (M2.5, M2.7 and M5).
Our Expertise
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- Regulatory Affairs
- Our regulatory consultants, who are experts in both Japanese and global regulations, establish regulatory strategies, and manage PMDA consultations and approval applications including writing various regulatory-related documents. Furthermore, we provide regulatory intelligence services.
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- Clinical Development
- Our clinical development consultants, who have extensive experience across a wide range of disease areas and various modalities, evaluate available data, perform gap analysis, and advise on clinical development strategies. We always try to utilize clinical data in other countries.
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- Non-clinical Development
- Our non-clinical consultants, who are knowledgeable in both Japanese and global regulations, evaluate existing non-clinical data, assess whether these data are acceptable to the Japanese authorities (gap analysis), and advise on and establish non-clinical development strategies. We identify non-clinical studies required for each development phase and for approval applications.
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- CMC
- Our CMC regulatory consultants, who are familiar with various modalities and a wide range of formulations, ensure compliance with Japan-specific requirements. We evaluate CMC data and advise on how to prepare CMC-related documents appropriately, and also write CMC documents for submission.
