IND Enabling Services
IND-enabling services are essential in the drug development process, ensuring new therapies are thoroughly evaluated for effectiveness and safety before clinical trials.
By assessing factors like efficacy, toxicity, and pharmacokinetic/pharmacodynamic (PK/PD) profiles, sponsors can make informed decisions about their drug candidates. This rigorous evaluation increases the chances of success in later stages and facilitates regulatory approvals. Ultimately, these services help mitigate risks, optimize trial design, and support the development of innovative therapies that can significantly enhance patient outcomes
Trust Our Pre-clinical Expertise
PK/PD
TME Scientific is dedicated to providing expertise in PK/PD modeling and simulation across a variety of techniques and applications, assisting clients in determining optimal dosage levels for efficacy studies. By blending scientific rigor with creative insight, we help clients select precise models that reveal the pharmacokinetic characteristics of compounds in early clinical trials.
Toxicology/Safety
Our preclinical research team, comprising board-certified toxicologists, regulatory specialists, and support staff, has over 20 years of experience in designing and conducting safety assessment programs. We utilize a wide variety of animal models and administration routes to evaluate acute and chronic toxicity, as well as carcinogenicity.
Efficacy
Efficacy services provide critical data that inform regulatory submissions and support the design of clinical trials. By establishing a clear understanding of a drug's efficacy early in the development process, we help sponsors with making informed decisions, reducing the risk of late-stage failures, and enhancing the chances of successful regulatory approval.
Related Products and Services
We take care of the evolving requirements of preclinical research and development, our scientific expertise will guide your through the next steps by delivering the necessary innovative products and services which lead you to your research success.
Cell Line Models
Clinically relevant cell models are critical for studies of molecular and cellular mechanisms of tumors, as well as for drug screening for cancer.
Research Models
An animal model is a non-human species used in biomedical research because it can mimic aspects of a biological process or disease found in humans.
Primary Cell Products
Primary cell products provide a useful tool for studying various aspects of infectious disease, immunology, and vaccine development.
