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GLP / IND-Enabling

Studies

BioLegacy is equipped and qualified to deliver fully integrated, GLP-compliant preclinical programs engineered to accelerate your timeline from candidate selection to IND submission. Our scientific and regulatory experts provide you with a safety, toxicology, and PK/TK data package that can pass the scrutiny of global regulatory bodies. We provide submission-ready SEND datasets with accelerated reporting, ensuring the entire process is streamlined to support a rapid and successful transition to the clinic.

  • Strict Compliance: FDA 21 CFR Part 58 and OECD GLP.
  • Independent Quality Assurance Unit (QAU): Functionally independent from study conduct, providing in-life phase inspections, data audits, and final report reviews to ensure GLP compliance and data integrity.
  • Accelerated Reporting: to support rapid decision-making and submission.
  • SEND Datasets: Submission-ready data packages help ensure compliance and facilitate efficient regulatory review.
  • IND-Enabling Battery: GLP repeat-dose toxicology and safety pharmacology studies. More as needed.
  • Multi-Species Expertise: Rodent and large animal studies to meet ICH guideline requirements.
  • Proven Regulatory Track Record: BioLegacy has a long history of successfully supporting sponsors’ IND and IDE submissions.
The Highest Standards of Compliance

Our commitment to regulatory compliance is embedded in a quality system designed for absolute adherence to the principles mandated by global authorities. Every IND-enabling study at BioLegacy is a direct reflection of FDA 21 CFR Part 58, where the designated Study Director assumes single-point-of-control (§ 58.33) for all aspects of study integrity. This is continuously verified by our functionally independent Quality Assurance Unit (§ 58.35) through documented inspections of critical phases. From meticulously maintained training records to the secure, long-term archiving of all raw data and specimens (§ 58.190), our processes are architected to ensure the complete traceability and reconstruction of your pivotal safety data. All studies are in strict adherence to OECD GLP principles, providing a concrete package for regulatory review worldwide.

  • Dedicated Study Director Oversight: Each GLP study is managed by an experienced Study Director who has single-point-of-control responsibility for study conduct and compliance, as mandated by 21 CFR § 58.33.
  • Robust SOP Framework: Comprehensive, validated Standard Operating Procedures (SOPs) govern all facility operations, processes, and methods to ensure consistency and reproducibility.
  • Full Data Traceability & Archiving: Meticulous record-keeping and secure archiving of all raw data, protocols, and specimens to allow for complete study reconstruction, per § 58.190 and § 58.195.
  • Independent Quality Assurance Unit (QAU): A functionally separate QAU conducts rigorous protocol, in-life phase, and final report audits to verify the integrity of the data and ensure adherence to all regulatory principles.
  • Validated Systems & Equipment: Rigorous qualification, calibration, and maintenance programs for all critical equipment and software, ensuring both the accuracy and reliability of all generated data and compliance with § 58.63.
  • Global Regulatory Acceptance: Our GLP framework is designed for international acceptance through adherence to OECD GLP principles, facilitating multinational submissions.
Data to Streamline Your Submissions

The final report is the ultimate deliverable of your preclinical study, and its quality, timeliness, and regulatory compliance are critical for a successful IND submission. BioLegacy’s reporting provides clarity, speed, and immediate regulatory utility. Our comprehensive, GLP-compliant final reports can be delivered on accelerated timelines with fully validated, submission-ready SEND (Standard for Exchange of Nonclinical Data) datasets. Our SEND-enabled partner laboratory works in concert with study directors and validated data capture systems to ensure a direct, audited flow of data into the required CDISC-compliant domains, streamlining your submission and facilitating efficient regulatory review.

  • Accelerated Report Generation: High-quality, submission-ready reports available on condensed timelines.
  • Partnered SEND Specialists: Experts on the creation, validation, and delivery of compliant SEND datasets for all applicable toxicology, safety, and efficacy studies.
  • Validated Data Management Systems: 21 CFR Part 11-compliant software for data capture and management.
  • Integrated Toxicokinetic (TK) Reporting: by experienced pharmacokineticists, integrated into the final toxicology report.
  • Submission-Ready Deliverables: You receive a complete, audited data package including the final report, SEND datasets, and supporting documentation, all formatted for regulatory submission.
  • Client-Centric Review Process: A collaborative and transparent report finalization process, including client review cycles, to ensure complete alignment and accuracy

Mitigating Regulatory and Clinical Risk with GLP Safety Studies

A successful IND submission rests on GLP safety studies which accurately characterize potential risks before first-in-human trials. BioLegacy is your single-source partner for the entire regulatory-mandated battery of studies. Our GLP-compliant program includes the required repeat-dose toxicology studies in both rodent and non-rodent species, a comprehensive ICH S7A/B-compliant safety pharmacology core battery, and a full panel of genetic toxicology assays. We deliver a complete toxicology data package to satisfy global regulatory agencies and confidently advance your therapeutic

  • Repeat-Dose Toxicology: Toxicology studies of varying durations (e.g., 28-day, 90-day) in both rodent and non-rodent species, as required by ICH guidelines, to identify potential target organs and establish a No Observed Adverse Effect Level (NOAEL).
  • Safety Pharmacology Core Battery: A comprehensive, ICH S7A/B-compliant program to assess your compound's effect on vital functions, including cardiovascular (telemetry), respiratory (plethysmography), and central nervous system (Irwin or FOB) assessments.
  • Genetic Toxicology Panel: A full suite of in vitro and in vivo assays to evaluate mutagenic and clastogenic potential, including Ames, MNA, and chromosome aberration assays, meeting ICH S2(R1) requirements.
  • Toxicokinetic (TK) & Pharmacokinetic (PK) Analysis: Integrated, GLP-compliant bioanalytical support to define the exposure-response relationship and provide exposure data for all toxicology studies.
  • DART (Developmental & Reproductive Toxicology): Embryo-fetal development (EFD) and other reproductive toxicology studies to support clinical trials in women of childbearing potential.
  • Immunotoxicology & Immunogenicity: Specialized assays, including T-cell dependent antibody response (TDAR), to assess potential immunotoxicity and anti-drug antibody (ADA) development for biologics.
Our GLP and IND-enabling studies provide confidence, compliance, and speed.
  • Accelerated reports with SEND data sets
  • Strict FDA 21 CFR Part 58 and GLP compliance
  • Submission-ready deliverables
  • On-site large & small animal toxicology
  • Full data traceability & archivingFull data traceability & archiving
  • Proven IND & IDE track record
Let’s get your program to the clinic. Contact us today.