Regulatory & Development Strategy

CoreMed is a leading strategic regulatory consulting firm in Japan. We have specialized in regulatory affairs since its establishment in 1998. We offer practical and strategic support in designing regulatory strategies, analyzing gaps between data and regulatory requirements, and preparing all types of regulatory submission dossiers, including marketing approval applications. We closely monitor legislations and pharmaceutical affairs laws (PMD-Act) and keep ourselves updated.

CoreMed covers all stages of development for all types of products, encompassing CMC, nonclinical, and clinical aspects. Our high professionalism, cultivated through consulting experience in a wide range of disease areas, allows us to meet the expectations of our clients. These areas include cancer, respiratory, cardiovascular, metabolic disorders, endocrinology, gastrointestinal, dermatology, orthopedics, psychiatry/central nervous system, ophthalmology, pain, hematology, infectious diseases/vaccines, and various modalities such as chemically synthesized drugs, antibody drugs, recombinant proteins, peptide drugs, oligonucleotide drugs, gene therapy products, and cell therapy products.

CoreMed's regulatory team helps clients

Regulatory Strategy

・Strategic regulatory development plan integrated with MHLW & PMDA/Japan, FDA and EMA requirements
・PMDA consultation meetings
・JNDA filing strategy
・Orphan Drug Designation (ODD)
・SAKIGAKE (Innovative/Pioneer Drug) Designation
・Cartagena Type-1Use Regulation approval
・Liaison between regulatory agencies and clients
・Up-to-date information of pharmaceutical and medical device regulations and guidelines/guidance in Japan
・R&D and Regulatory Due Diligence
・Gap analysis and Assessment of data
・Feasibility study
・GxP compliance inspection
・Regulatory submission dossier (CTD/eCTD, DMF, Foreign Manufacturer Accreditation (FMA), Clinical Trial Notification (CTN) etc.)
・Responses to inquiries from the authorities
・In-Country Caretaker for Master File (J-DMF)
・Agent for Foreign Manufacturer Accreditation (FMA)

For further information on our services, please feel free to contact us.

Search by Our Services

Regulatory & Development Strategy

PMDA Consultation

CTD & Regulatory Document Writing

Search by Our Expertise

Regulatory Affairs

Clinical Development

Non-clinical Development

CMC