1.Translation service (pharmaceuticals*, agrochemicals, foods, etc,)
・Translation of study reports, application materials, etc. (English translation,
Japanese translation)
2.Quality Check service (pharmaceuticals*, agrochemicals, foods, etc.)
・Raw data, study reports, various application materials, etc.
3.Support for preparing application materials (pharmaceuticals*, agrochemicals)
・Pharmaceuticals: IND/CTA submission documents,
Investigator’s Brochure
CTD (nonclinical part)
・Agrochemicals: OECD Dossier
4.Regulatory submission support (pharmaceuticals*, agrochemicals)
・Response to inquiries after application, face-to-face meeting of regulatory authorities
5.Project development management, nonclinical evaluation of license-in products,
support for licensing-out (pharmaceuticals*)
・Consultation for clinical introduction/phase up of developing projects
・Measure for Due Diligence of license-in project, license-out strategy advice, etc.
6.Education and training
・Histology slide-reading training for pathologists
・Consulting service related to GLP regulation and reliability standards
・Translation of study reports, application materials, etc. (English translation,
Japanese translation)
2.Quality Check service (pharmaceuticals*, agrochemicals, foods, etc.)
・Raw data, study reports, various application materials, etc.
3.Support for preparing application materials (pharmaceuticals*, agrochemicals)
・Pharmaceuticals: IND/CTA submission documents,
Investigator’s Brochure
CTD (nonclinical part)
・Agrochemicals: OECD Dossier
4.Regulatory submission support (pharmaceuticals*, agrochemicals)
・Response to inquiries after application, face-to-face meeting of regulatory authorities
5.Project development management, nonclinical evaluation of license-in products,
support for licensing-out (pharmaceuticals*)
・Consultation for clinical introduction/phase up of developing projects
・Measure for Due Diligence of license-in project, license-out strategy advice, etc.
6.Education and training
・Histology slide-reading training for pathologists
・Consulting service related to GLP regulation and reliability standards
*Covering non-clinical studies (pharmacology, pharmacokinetics, and toxicology)
