Nonclinical Studies

Accelerate your drug candidate’s transition from early discovery to regulatory approval with CD BioSciences’ fully integrated Nonclinical Studies solutions. We offer robust, fully GLP-compliant and exploratory evaluation packages tailored to small molecules, biologics, cell and gene therapies, and other advanced therapeutic modalities, with study strategies adapted to modality-specific regulatory requirements.

Combining expertise in safety pharmacology, general and specialty toxicology, pharmacokinetics and toxicokinetics (PK/TK), bioanalysis, and quantitative histopathology, our multidisciplinary nonclinical platform is engineered to to generate high-integrity data packages supporting IND applications and subsequent regulatory development.

Core Nonclinical Services

IND-Enabling & Regulatory Solutions

Safety Pharmacology & Toxicology

Comprehensive GLP and exploratory toxicology testing to establish safe clinical dosing windows.

• Single & repeated-dose toxicity, safety pharmacology core battery (cardiovascular, CNS, respiratory).

• Genotoxicity, immunotoxicity, and local tolerance evaluation compliant with ICH guidelines.

PK/TK & Bioanalysis

Quantitative ADME, pharmacokinetics, toxicokinetics, and assay validation for small & large molecules.

• In vitro/in vivo ADME characterization, PK profiling, and TK exposure assessments.

• LC-MS/MS, LC-HRMS, and ligand binding assays (ELISA, MSD) under GLP standards.

Toxicologic Histopathology

Experienced toxicologic pathologists evaluating target organ toxicity and structural changes.

• Routine H&E histopathology, special histological staining, and tissue cross-reactivity (TCR).

• Quantitative image analysis and biomarker correlation in target organ tissue sections.

IND-Enabling Study Packages

Turnkey study design and comprehensive documentation to streamline regulatory filings.

• Integrated nonclinical program management aligned with relevant FDA, EMA, NMPA, and ICH requirements and guidance.

• SEND-compliant data formatting and study reports for seamless eCTD submission.

Our Experience

Therapeutic Modalities	Study Scope & Capabilities
Monoclonal & Bispecific Antibodies Antibody-Drug Conjugates (ADCs) Oligonucleotide Therapeutics Synthetic Peptides & Polypeptides Recombinant Proteins & Enzymes Small Molecule Entities Prodrug Architectures Vaccine Formulations Repurposed Drug Formulations (e.g., FDA 505(b)(2))	Acute, subchronic, and chronic nonclinical toxicity evaluation In vitro and in vivo safety pharmacology assessments Comprehensive pharmacokinetic (PK) and toxicokinetic (TK) profiling Broad coverage across therapeutic areas and disease indications Multiple routes of administration (oral, parenteral, topical, inhalation, etc.) Testing across standard nonclinical models and specialized research species

Therapeutic Modalities

Study Scope & Capabilities

Monoclonal & Bispecific Antibodies
Antibody-Drug Conjugates (ADCs)
Oligonucleotide Therapeutics
Synthetic Peptides & Polypeptides
Recombinant Proteins & Enzymes
Small Molecule Entities
Prodrug Architectures
Vaccine Formulations
Repurposed Drug Formulations (e.g., FDA 505(b)(2))

Acute, subchronic, and chronic nonclinical toxicity evaluation
In vitro and in vivo safety pharmacology assessments
Comprehensive pharmacokinetic (PK) and toxicokinetic (TK) profiling
Broad coverage across therapeutic areas and disease indications
Multiple routes of administration (oral, parenteral, topical, inhalation, etc.)
Testing across standard nonclinical models and specialized research species

Nonclinical Studies Across the Drug Development Lifecycle

Discovery / Early Research

Preclinical Development

Phase I

Phase II

Phase III

NDA/BLA

Nonclinical Development & Safety Assessment

Our nonclinical studies encompass early preclinical and exploratory studies, IND-enabling GLP nonclinical studies, ongoing additional nonclinical studies throughout clinical Phases I–III, and comprehensive nonclinical packages supporting NDA/BLA submissions.

Advance Your Candidate into Nonclinical & IND-Enabling Development

Partner with CD BioSciences to access advanced nonclinical study design, GLP-compliant bioanalysis, and expert regulatory support.

Contact Our Experts