Nonclinical Safety

CORE AREAS OF EXPERTISE

BlueRidge Life Sciences Nonclinical Safety helps pharmaceutical and biotech clients design, manage, and optimize nonclinical programs with the scientific rigor and regulatory foresight needed to move safely and efficiently toward clinical trials. Our team supports more than 30 therapeutic areas and modalities, including traditional small molecules, biologics, cell and gene therapies, and rare disease treatments.

  • We guide clients through early development with precision, foresight, and confidence:

    • Develop integrated toxicology strategies tailored to indication, route, and patient population

    • Identify appropriate study models and address challenges such as species selection — including programs with no relevant species

    • Facilitate regulatory meetings and guide toxicology response strategies across FDA, EMA, Health Canada, Australia, New Zealand, and MHRA

    • Provide strategic regulatory guidance and document review throughout development

  • We oversee critical GLP and non-GLP studies and translate results into actionable insights, seamlessly integrating them into early-phase clinical development strategies to drive informed, accelerated decision-making:

    • Manage a wide variety of studies ranging from in vitro toxicology to general toxicology to reproductive and developmental to carcinogenicity and more

    • Guide clinical dose selection, escalation strategies, and clinical monitoring plans

    • Ensure alignment between nonclinical strategy and clinical program goals

    • Represent toxicology in cross-functional development discussions and at regulatory meetings

  • We help clients prepare regulatory filings that comply with global standards, ensuring seamless approval pathways and accelerated time to market:

    • Nonclinical sections for INDs, CTAs, NDAs, BLAs, and CTDs

    • Prepare and review nonclinical expert reports and supporting documentation

    • Develop tabulated and narrative summaries for pharmacokinetics and toxicology

    • Contribute to 70+ INDs/CTAs submitted since 2012

STRATEGIC SOLUTIONS IN NONCLINICAL DEVELOPMENT

Flexible Approaches for Rare Disease Programs

For rare and serious conditions, nonclinical safety programs often require customized approaches. BlueRidge helps clients:

  • Align with regulatory guidance that allows shortened or reduced toxicology packages 

  • Establish First-in-Human doses

  • Navigate pediatric requirements, including justification for deferring or omitting juvenile toxicity studies when appropriate

  • Address global differences in requirements for rare disease indications

  • Support programs with no relevant species through alternative model strategies

Data-Driven Risk Assessment and Modeling

We drive smarter, earlier decision-making through risk-informed assessments and advanced predictive tools. Our team helps clients:

  • Prepare carcinogenicity and reproductive toxicity assessments

  • Develop monographs for excipients and impurities

  • Assess metabolite safety to meet regulatory thresholds

  • Use (Q)SAR models like Derek Nexus, Leadscope, and Meteor

  • Justify waivers and streamline regulatory submissions with data-backed evidence

SPECIALIZED CAPABILITIES THAT SET US APART

  • Target Liability and Risk Assessments

  • Metabolite Safety Qualification and Assessment

  • Impurity and Excipient Liability Assessments

  • Expertise in Programs with No Relevant Nonclinical Species

  • Strategic Regulatory Guidance and Planning

  • Due Diligence Support (In- and Out-Licensing)

  • Preparation of Nonclinical Expert Reports

  • Regulatory Document Preparation and Review

  • Poject Team and Regulatory Meeting Attendance

  • Support for Specialized Routes of Administration

THERAPEUTIC AREAS & MODALITIES WE SUPPORT

BlueRidge supports a wide range of product types and therapeutic areas, from small molecules to gene therapies.

  • Intravenous, subcutaneous, intrathecal, inhalation, dermal, oral and more

  • Traditional drugs, botanicals, peptides, oligonucleotides

  • Antibodies, ADCs, biosimilars, fusion proteins, bispecifics, vaccines, immunotherapies

  • Cell and gene therapies, novel constructs

  • Oncology, neurology, ophthalmology, autoimmune disease, metabolic disorders, cardiovascular, rare diseases, and more

Ready to Build a Stronger Nonclinical Foundation?

Contact us today to discuss your development program and learn how BlueRidge can help you reduce risk, streamline timelines, and move forward with confidence.