Mediford Corporation supports development of pharmaceutical products by providing a series of nonclinical and clinical services from the early stages of drug development to application for manufacturing and marketing approval.

• In addition to possessing a wide range of efficacy models in pharmacological evaluation, we are also able to offer development of models according to our clients’ needs.
• For toxicity and safety pharmacology studies, various safety tests necessary for application of manufacturing and marketing approval are conducted under pharmaceutical GLP conditions in compliance with ICH guidelines.
• We can also comprehensively address Pharmacokinetic studies including exploratory tests supporting in-vivo and in-vitro study with a menu of analyzing blood cell transfer rate, protein binding rate, drug concentrations, drug metabolizing enzymes, or metabolites.
• Seamless analytical services are provided which enable smooth transitions from nonclinical to clinical stage. A variety of items necessary for evaluating test substances in an analytical menu including Determination of Drug Concentrations in biological samples in clinal stage, Biomarker Analysis, evaluation of effect on immune cells, or evaluation of effect on gene expressions are conducted under pharmaceutical GLP conditions.
• With our central laboratory service, it is possible to pick up samples from test sites all over the Japan and report test results with high precision. Collaboration with partner laboratories outside Japan is also available.
• Mediford Corporation provides medical writing services to support application for regulatory approval. We produce high quality documents which include investor's brochure (IB), non-clinical sections of IB and CTD with QC/QA verification.

If within one project there are multiple studies in a nonclinical stage, a project manager will serve as a point of contact for the client and through smooth communication present an efficient study protocol, accurately conduct progress management and reporting on the project, and present comprehensive evaluation results consistent among studies. In a clinical stage, a project manager dedicated to each study manages and controls the entire process from the preparation to the termination of the study.

Our staff members have extensive experience, skills, and knowledge in their areas of expertise and will provide high quality and reliable results in all studies under GLP and reliability criteria.

At mediford, a system to accept studies of regenerative medicine products has been developed.

• We are certified with GLP for regenerative medicine products and we conduct toxicity studies necessary for application for manufacturing and marketing approval in accordance with GLP and related guidelines.
• In regard to pharmacological studies, we have disease models in various categories such as hepatitis, peripheral artery disease, arthritis, myocardial infarction, and cerebral infraction, and also develop models according to our clients’ requests.
• We are able to offer biodistribution studies for pharmacokinetics.
• In clinical studies, evaluation of immune system by flow cytometry and determination of biomarkers are conducted under pharmaceutical GLP conditions.
• With our central laboratory service, it is possible to pick up samples from test sites all over Japan and report test results with high precision. Collaboration with partner laboratories outside Japan is also available.
• We are also entrusted with medical writing work as pharmaceutical application support. We provide high quality documents with QC/QA verification which are non-clinical sections of investigational medicinal product dossiers (IMPD), investigator's brochures (IB), and common technical documents (CTD).

If multiple studies are consigned for one project in a nonclinical stage, a project manager will act as a point of contact with the client, present an efficient study plan for the project, manage accurate progress and adequately report through smooth communication while also presenting comprehensive evaluation results consistent among studies. In a clinical stage, a project manager dedicated to each study manages and controls the entire process from the preparation to the termination of the study.

Our staff has extensive experience, expertise, and knowledge and will provide reliable results in all studies including GLP and reliability criteria.

Mediford Corporation has developed a system for conducting non-clinical studies of medical devices. Since being confirmed to comply with medical device GLP in safety studies (May 28, 2018), we have conducted toxicity studies in full compliance with GLP and/or other related guidelines necessary for applications of manufacturing and marketing approval. Our personnel have extensive experience, skills, and knowledge in their areas of responsibility and are able to provide high quality and reliable results in all studies that include GLP and reliability criteria.

If within one project there are multiple studies, a project manager will serve as a point of contact for the client and through smooth communication present an efficient study protocol, accurately conduct progress management and reporting on the project, and present comprehensive evaluation results consistent among studies.

Mediford Corporation provides medical writing services to support application for regulatory approval. We produce high quality documents with QC/QA verification which are non-clinical sections of investigational medicinal product dossiers (IMPD), investigator's brochures (IB), and common technical documents (CTD).

Mediford Corporation conducts various toxicity studies in compliance with GLP for agricultural chemicals and OECD guidelines necessary for application for pesticide registration.

Mediford Corporation provides reliable data through various safety studies that are required for approval of specified health supplementary foods and food additives, etc. We can conduct these studies in compliance with pharmaceutical GLP.

Mediford Corporation provides highly reliable data required for application for marketing approval of quasi drugs, etc., through various toxicity studies listed below. We can conduct these studies in compliance with pharmaceutical GLP.

Mediford Corporation provides highly reliable data required for application for approval of veterinary drugs through various toxicity studies listed below. We can conduct these studies in compliance with GLP for veterinary drugs.

Mediford Corporation conducts the following studies related to safety assessment of chemical substances.
In response to our client's requests, we offer a wide range of services from simple studies to various safety studies which apply to Japanese Chemical Substances Control Law (CSCL) or Industrial Safety and Health Law GLP.