Investigational New Drug (IND)-Enabling Capabilities
Integrated Service Solutions for Your IND Success
As a leading CRO in toxicology and preclinical research, we prioritize efficiency and close collaboration with our clients to smoothly transition to first-in-human studies. We expertly guide you through every phase of your pre-clinical drug development journey, providing a comprehensive suite of services for IND applications. This includes everything from lead candidate optimization, toxicity, and safety testing to bioanalytical testing and dose formulation.
The Scantox team leverages its advanced program management skills and decades of in-depth experience in key service areas to ensure your project’s success.
These solutions include:
Regulatory Toxicology Testing
General Toxicology
Speciality Toxicology Assessments
Comprehensive histopathology examination including scanning
Safety Pharmacology
Implementation of ICH S7A core battery and supplementary tests for CNS, cardiovascular, and respiratory evaluations
QT interval prolongation studies in line with ICH S7B and E14 guidelines
Bioanalytical Testing
Expert LCMS/MS method development and validation services
GLP-compliant bioanalysis for all toxicology studies
Drug Formulation
Custom formulation development for optimal drug delivery
Analytical development and validation for product characterization
Production of non-GMP and GMP batches for clinical trials
What Scantox Delivers
Our team conducts over 30 IND-enabling studies annually that pave the way for clinical trial approval. As your partner in critical toxicology studies, Scantox will:
- Develop clear customized research programs for small molecule assessment
- Conduct tailored preclinical studies in line with IND requirements and Good Laboratory Practice (GLP) standards.
- Provide high-quality data on time that guides your decisions
- Deliver a pre-clinical data report and a Standard for Exchange of Nonclinical Data (SEND) dataset accompanying your study, required for submission agencies like the FDA or MHRA.
Why choose Scantox?
Our suite of IND-supporting services, coupled with our mid-size organization, means entering a partnership with a team dedicated to scientific excellence and impactful engagement.
We combine our extensive expertise in different species and therapeutic areas to address your challenges and act as an extension of your team. Our scientific experts collaborate closely with you on strategic planning, timely communication, and delivering solutions and data for clinical proof-of-concept.
Our commitment extends to the highest standards of animal welfare, which is an integral part of our care. Our staff is thoroughly trained in caring for laboratory animals, prioritizing their well-being and the environment they live in, while strictly adhering to regulatory standards.
Contact us to discuss how our customized IND-enabling solutions can expedite your path to clinical trials.
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