COMPLETE PACKAGES

IPMC-TMC takes over the complete responsibility for a product from the client. IPMC-TMC will then perform the standard programs as required (EPA, FDA, J-MHW, METI, EU and OECD) for AG-Products, Industrial Chemicals and Pharmaceuticals. This includes single dose and repeated dose toxicity in all main species for a given testing area (Toxicology, Aquatic Ecotoxicology, Terrestrial Ecotoxicology, Beneficial Organisms) by various application routes. These activities also include fertility and reproduction studies as well as pathology in case of kidney specific studies (see Renal Toxicology).

These standard programs will not be carried out by IPMC-TMC directly but will be subcontracted to GLP-certified contract laboratories of our choice, i.e. those laboratories that have demonstrated excellence in planning, implementation, evaluation and reporting in our past experience. IPMC-TMC will plan, direct and monitor the studies and carry out the final reporting in lieu of the client and ensures the highest quality achievable for the client. This will secure optimal realization of the client interests with negligible workload and therefore highly efficient product management for the client.

STUDY MONITORING

You have chosen a contract laboratory of your preference for a given study type. IPMC-TMC will provide you with a dedicated study monitor who will ensure the highest achievable quality in study design, study protocol, study implementation, data logging, data intermediate reporting, data interpretation and final reporting &filing. In addition to securing scientific excellence and adherence to GLP standards, the IPMC-TMC study monitor will maintain close contact with the customer and the contract laboratory to ensure adherence to previously agreed upon time schedules.

CONSULTING

You present the specific problem and IPMC-TMC provides you with expert advice for achieving the best possible solutions in a cost and time efficient manner. Due to the high interaction of IPMC-TMC with the customer representative, highest achievable customer satisfaction is guaranteed:

• all steps to be taken will be laid out and agreed upon beforehand
• results achieved and potential ramifications of the data obtained will be discussed in detail and presented as a written document at every step taken
• Final documentation and reporting will be provided in the format required by the customer for filing with the respective governmental institutions

TAILORED SOLUTIONS

There is an increasing demand to obtain more detailed information from toxicity studies while reducing both the numbers of animals used and the discomfort induced by experimental techniques. In many cases regulatory authorities would like to see additional studies, usually not standardized protocols, for enhanced clarification of specific findings. IPMC-TMC provides support in developing tailored studies to address these needs together with the client.

PROSPECTIVE STUDIES / INVESTIGATIVE TOXICOLOGY

Frequently the client is faced with a finding in the standard testing program that cannot be answered based on the present experience base. However, it is realized that the regulatory authorities would ask for an improved clarification of the finding in order to accept the data presented for risk characterization and assessment. IPMC-TMC will discuss the situation with the client and propose additional strategies in order to resolve the situation in a time- and cost efficient manner.