Mediford 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 offer a comprehensive menu of pharmacokinetic studies, including exploratory studies, such as blood cell distribution, protein binding rate, drug concentration measurement, and measurement of drug-metabolizing enzymes and metabolites.
• We provide seamless analytical services to facilitate smooth progression from nonclinical to clinical studies. We perform a variety of analytical services required for the evaluation of test substances, such as measurement of drug concentration in biological samples, measurement of biomarkers, evaluation of effects on immune cells, and evaluation of effects on gene expression in the clinical stage in compliance with GLP for pharmaceuticals.
• We provide highly accurate clinical test results by collecting samples from medical institutions nationwide and conducting batch testing through our central laboratory service. We can also collaborate with overseas laboratories.
• We also provide 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).

Within one project conducting 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. Also in the clinical phase, a dedicated project manager for each study oversees and manages the entire process from preparation to completion of the study.

Each of our staff member has extensive experience, skills, and knowledge in his/her area of responsibility and provides reliable results for all studies, including GLP and Standards of Reliability of Application Data.

At Mediford, we have strengthened our capabilities to provide nonclinical safety studies of regenerative medicine products.

• 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 regards to pharmacological studies, we have disease models in various categories such as hepatitis, peripheral artery disease, arthritis, myocardial infarction, and cerebral infarction, and also develop models according to our clients’ requests.
• We are able to offer biodistribution studies for pharmacokinetics.
• In clinical trials, we evaluate the immune system by flow cytometry and measure various biomarkers in compliance with GLP for pharmaceuticals.
• We provide highly accurate clinical test results by collecting samples from medical institutions nationwide and conducting batch testing through our central laboratory service. We can also collaborate with overseas laboratories.
• We also provide 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).

Within one project conducting 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. Also in the clinical phase, a dedicated project manager for each study oversees and manages the entire process from preparation to completion of the study.

Each of our staff member has extensive experience such as in the area of small molecule pharmaceuticals, skills, and knowledge in his/her area of responsibility and provides reliable results for all studies, including GLP and Standards of Reliability of Application Data.

Mediford is fully capable of conducting nonclinical studies of medical devices. Since being confirmed to comply with medical device GLP in safety studies (August 23, 2006), we have been conducting 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 and skills in their areas of responsibility and are able to provide high quality and reliable results in all studies that include GLP and Standards of Reliability of Application Data.

Within one project conducting 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 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 conducts various toxicity studies in compliance with GLP for agricultural chemicals and OECD guidelines necessary for application for pesticide registration.

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