Biolegacy Capabilities – biolegacy

Deep therapeutic area expertise and experience with a broad range of validated models enable us to provide top-quality preclinical studies for our sponsor partners. BioLegacy’s other capabilities are what give us an edge. From IND-enabling studies with SEND data packages to our flexible, world-class vivarium accommodating almost any model organism and our range of advanced bioanalytical platforms to ensure the most robust data, BioLegacy does it all under a single roof.

Having everything in one facility means that all our specialists talk to each other directly and frequently. It means that we don’t have to worry about data quality issues due to shipping and handling or the time between sampling and analysis. It means greater efficiency and flexibility. All things that help get your study to a more certain outcome more quickly.

GL & IND-Enabling Studies: Get the definitive data you need with studies designed to exceed FDA, EMA, OECD, and other regulatory bodies’ standards.

SEND Data Packages: Obtain data in accordance with the Standard for Exchange of Nonclinical Data to streamline your regulatory submissions.

World-Class Small & Large Animal Vivarium: Husbandry experts from mice to NHPs in a new, start-of-the-art, AAALAC-accredited facility

Advanced Bioanalytical Platforms: Meso Scale Discovery, flow cytometry, advanced microscopy,a full histology suite, digital PCR, and much more.

A successful IND submission depends on clean data and regulatory precision. BioLegacy’s GLP-compliant programs provide this foundation with speed and integrity. We deliver the definitive safety, toxicology, and PK/TK data packages required by global regulatory agencies, with accelerated report timelines and submission-ready SEND datasets to streamline the review process and shorten your path to the clinic. With experience contributing to FDA INDs, EMA CTAs,PMDA CTNs, and other regulatory applications, BioLegacy will help ensure smooth approval for your first-in-human trials.

Rigorous GLP Compliance: : Strict adherence to FDA 21 CFR Part 58 and OECD guidelines, overseen by an independent Quality Assurance Unit (QAU).
Accelerated Reporting Timelines:: Streamlined workflow delivers high-quality reports on an accelerated schedule to support rapid decision-making and submission.
Integrated SEND Dataset Delivery:: Submission-ready SEND data packages ensure full FDA compliance and facilitate efficient regulatory review.
Comprehensive IND-Enabling Battery:: Full suite of GLP studies required for IND, including repeat-dose toxicology and safety pharmacology.
Multi-Species Expertise for Regulatory Success:: In-house capabilities for both rodent and non-rodent (canine, NHP, etc.) studies to meet ICH guideline requirements.
Proven Regulatory Track Record:: Extensive experience in successfully supporting IND and IDE submissions for a wide range of therapeutic modalities.

The quality and reproducibility of preclinical data are fundamentally dependent on the quality of the in vivo environment. BioLegacy’s AAALAC-accredited facilities provide a precisely controlled, pathogen-free environment that exceeds regulatory standards, supported by a team of highly trained husbandry and veterinary specialists who provide unparalleled care for all species, with dedicated expertise in the complex social and behavioral needs of non-human primates. With the ability to house and support animals from mice to NPHs, we ensure you have the exact platform best suited for your study.

AAALAC International Accreditation:: BioLegacy commits to the highest global standards for animal care and use, for both data quality and ethical integrity.
Comprehensive Multi-Species Housing:: Purpose-built housing for a diverse range of species,including mice, rats, hamsters, guinea pigs, rabbits, pigs, sheep, dogs, and non-human primates.
Advanced Environmental Control:: Centralized monitoring systems (Edstrom Watchdog) for precise, real-time environmental control.
Specialized NHP Enrichment Programs:: Dedicated behavioral management and enrichment programs tailored to the complex psychological and social needs of non-human primates.
Expert Veterinary & Husbandry Staff:: On-site team of board-certified veterinarians and AALAS-certified technicians providing round-the-clock care and scientific support.

Translating biological samples into a clear, quantitative understanding of your therapeutic's activity is the core mission of our bioanalytical group. We provide a comprehensive suite of analytical services to deliver definitive data on drug exposure, target engagement, and pharmacodynamic response. Using a diverse array of advanced platforms — from Meso Scale Discovery and ELISA for protein quantification, to flow cytometry for immunophenotyping, qPCR/dPCR for gene expression, and quantitative histology for tissue-level analysis — we provide robust, decision-driving data and propel your program forward.

Multi-Platform Ligand Binding Assays (LBAs):: BioLegacy develops and validates high-resolution immunoassays on platforms including ELISA and electrochemiluminescence (MSD) for PK, ADA, and biomarker analysis.
Advanced Cellular & Gene Expression Analysis:: In-depth cellular characterization via multi-color flow cytometry and precise nucleic acid quantification using real-time (qPCR) and digital PCR (dPCR).
Quantitative Histology & Image Analysis:: On-site pathology services offering advanced IHC/ISH and automated image analysis to provide quantitative, tissue-specific biomarker data.
Full Method Lifecycle Support:: From de novo method development and validation to the high-throughput analysis in both non-GLP and GLP studies.
Integrated PK/PD & TK Analysis:: Rapid sample turnaround and expert interpretation, correlating drug exposure with biological activity.

Let’s Get You To IND/IDE!

Don’t wait to advance your
pipeline.

Working with BioLegacy was a great experience. The team was very responsive and their dedication to my study was obvious. They caught a problem with our study design early on that could have resulted in serious flaws in our data, were able to suggest and execute protocol changes mid-study, and with minimal impact on cost and schedule. I would recommend BioLegacy to anyone!

Dr. FirstName LastName

Vice President of Department

Example Pharmaceuticals