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Nonclinical Services

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Sectoral Service

Pharmaceutical Products

LSI Medience supports development of pharmaceutical products by providing a series of nonclinical 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 clientsf 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. Our staff members have extensive experience and skills in their areas of expertise and will provide high quality and reliable results in all studies under GLP and Reliability Criteria. Furthermore, we also conduct ecotoxicity studies for environment risk assessment.

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.

LSI Medience provides medical writing services to support application for regulatory approval. We produce high quality documents which include investorfs brochure (IB), non-clinical sections of IB and CTC with QC/QA verification.

Pharmaceutical Product Development Service

Pharmaceutical Product Development Service Pharmaceutical Product Development Service

Regenerative medicine products

At LSI Medience, a system to accept nonclinical safety 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 regards 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 clientsf requests. We are able to offer biodistribution studies for pharmacokinetics. Our staff has extensive experience and expertise, and will provide reliable results in all studies including GLP and criteria for reliability.

If multiple studies are consigned for one project, the 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 between the studies.

We are also entrusted with medical writing work as medicinal 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).

Support service of regenerative medicine products

Support service of regenerative medicine products Support service of regenerative medicine products

Acceptable study list at LSI Medience
(Compliance with GLP for regenerative medicine products is available)

In vivo Animal species: General animal and immunodeficient animal (nude mouse/NOG mouse/nude rat/others)
Single dose toxicity study
Repeated dose toxicity study
Tumorigenicity study
In vitro Soft agar colony formation assay

Acceptable study list at LSI Medience
(Compliance with criteria for reliability is available)

Hepatopathy model Non-alcoholic steatohepatitis (NASH)
Carbon tetrachloride-induced hepatitis (acute/chronic)
Concanavalin A (ConA)-induced hepatopathy
Thioacetamide (TAA)-induced liver fibrosis
Peripheral arterial disease (PAD) model Hind limb ischemia
Arthritis model Type U Collagen-induced arthritis
Osteoarthritis
Myocardial infraction model Ischemic reperfusion, permanent occlusion
Cerebral ischemia model Transient focal cerebral ischemia

In addition, please contact us about the possibility of conducting other studies using the test items of pharmacological study.

Medical Device

LSI Medience 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 and skills 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.

LSI Medience 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).

List of Studies/Tests Available at LSI Medience

  • Cytotoxicity Tests
  • Acute Systemic Toxicity Tests
  • Subacute Toxicity Tests
  • Chronic Toxicity Tests
  • Irritation/Intracutaneous Reactivity Tests
  • Sensitization Studies (GPMT)
  • Genotoxicity Studies
  • Pyrogen Tests
  • Implantation Tests
  • Hemocompatibility Tests (hemolysis)
  • Carcinogenicity studies
  • Kinetic Studies (blood concentration measurement, etc.)
  • Immunotoxicity Studies
  • Reproductive/Developmental Toxicity Studies

Agricultural Chemicals

LSI Medience conducts various toxicity studies in compliance with GLP for agricultural chemicals and OECD guidelines necessary for application for pesticide registration. In addition, we are also able to conduct GLP compliant tests on the effects on aquatic animals and plants.

List of Studies/Tests Available at LSI Medience

  • Acute Oral Toxicity Tests
  • Acute Dermal Toxicity Tests
  • Acute Inhalation Toxicity Tests
  • Skin Irritation Tests
  • Primary Eye Irritation Tests
  • Skin Sensitization Tests
  • Repeated Dose 90-day Oral Toxicity Studies
  • Repeated Dose 21-day Dermal Toxicity Studies
  • Repeated Dose 90-day Inhalation Toxicity Studies
  • Repeated Dose 1-year Oral Toxicity Studies
  • Carcinogenicity Studies
  • Combined Repeated Dose 1-year Oral Toxicity/Carcinogenicity Studies
  • Reproduction Toxicity Studies
  • Teratogenicity Tests
  • Mutagenicity Studies (reverse mutation tests, chromosomal aberration tests, and micronucleus tests)
  • Action Mechanism Elucidation Studies (observation of general conditions, central nervous system, respiration, cardiovascular system, renal function, autonomic nervous system, skeletal muscle, hematological system, digestive system, and others)
  • Animal Metabolism Studies (ADME studies)
  • Growth Inhibition Tests in Algae
  • Acute Immobilization Tests in Water Fleas
  • Reproduction Tests in Water Fleas
  • Acute Toxicity Tests in Fish
  • Early Life Stage Toxicity (ELST) Tests in Fish
  • Bioaccumulation Studies
  • Physical/Chemical Property Tests

Food (Specified Health Supplements, Food Additives)

LSI Medience 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.

List of Studies/Tests Available at LSI Medience

  • Single Dose Toxicity Studies
  • Repeated Dose 28-day Toxicity Studies
  • Repeated Dose 90-day Toxicity Studies
  • Mutagenicity Studies (reverse mutation tests, chromosomal aberration tests, and micronucleus tests)
  • Repeated Dose 1-year Toxicity Studies
  • Reproduction Studies
  • Teratogenicity Tests
  • Carcinogenicity Studies
  • Combined Repeated Dose 1-year Toxicity/Carcinogenicity Studies
  • Antigenicity Studies
  • General Pharmacology Studies (effects on general conditions, central/autonomic nervous system, smooth muscle/respiration, cardiovascular/digestive system, and fluid/electrolyte metabolism)
  • Pharmacokinetic Studies
  • Pharmacology Studies

Quasi Drugs and Others (Quasi Drugs and Cosmetics)

LSI Medience 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.

List of Studies/Tests Available at LSI Medience

  • Single Dose Toxicity Studies
  • Repeated Dose Toxicity Studies
  • Genotoxicity Studies
  • Carcinogenicity Studies
  • Reproductive Developmental Toxicity Studies
  • Skin Sensitization Tests
  • Local Irritation Tests
  • Photosensitization Tests
  • Phototoxicity Tests
  • Pharmacokinetic Studies (ADME studies)

Veterinary Drugs

LSI Medience 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.

List of Studies/Tests Available at LSI Medience

  • Acute Toxicity Tests
  • Subacute Toxicity Tests
  • Chronic Toxicity Tests
  • Local Irritation Tests
  • Reproductive/Developmental Toxicity Studies
  • Mutagenicity Studies
  • Carcinogenicity Studies
  • Pharmacology Studies
  • General Pharmacology Studies
  • Adsorption, Distribution, Metabolism, and Excretion Studies (ADME studies)

Chemical Substance

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