Your Partner on the Road ofInnovative Medicine

Your Partner on the Road of
Innovative Medicine

We are committed to meeting challenges side-by-side with you—to discover cures and drive progress together.

Project Management

  • HiLand Biosciences | Global CRO for IND-Enabling Non-Clinical & CMC Development

    Strong execution in tech transfer, scale-up, IND filing, clinical trial supply, and NDA submission.

  • Proven Record:

    Proven Record:

    5000+:Research project;
    150+: CMC package for IND;
    200+:Approval for Clinical trials.

  • HiLand Biosciences | Global CRO for IND-Enabling Non-Clinical & CMC Development

    Experienced in global IND filings and regulatory engagement, especially valuable for startups.

R&D Innovation Capability

We are scientists at heart—collaborative, curious, and solution-driven. We go beyond routine services to support clients working on the scientific frontier.

  • 30 +

    Patents Filed

  • 100 +

    Scientific Paper Published

  • 40 +

    Proficiency Verifications

  • 300 +

    Validated Testing Methods

  • 7 M+

    Research Grants Funded (in US$)

Media optimization for production

Media optimization for production

Novel ADC design strategies

Novel ADC design strategies

Development of new assay platforms

Development of new assay platforms

Establishment of disease models

Establishment of disease models

Integration of emerging technologies

Integration of emerging technologies

Advanced Facilities and Expert Team for Preclinical Study

  • HiLand Biosciences | Global CRO for IND-Enabling Non-Clinical & CMC Development
  • A multidisciplinary team with over a decade of proven expertise in GLP-compliant studies, FDA regulatory submissions, pathology, and molecular biology

  • HiLand Biosciences | Global CRO for IND-Enabling Non-Clinical & CMC Development
  • HiLand Biosciences | Global CRO for IND-Enabling Non-Clinical & CMC Development
  • Key labs equipped with specialized instruments for ophthalmic, pediatric, and bioanalytical research

  • Accredited non-clinical lab with FDA/OECD GLP compliance, AAALAC certification for animal welfare, CMA & CNAS testing and calibration recognition, and robust QA system

  • HiLand Biosciences | Global CRO for IND-Enabling Non-Clinical & CMC Development
  • HiLand Biosciences | Global CRO for IND-Enabling Non-Clinical & CMC Development
  • Access to ABSL-2, BSL-2+, and BSL-3 environments, full support for animal exams and testing

  • HiLand Biosciences | Global CRO for IND-Enabling Non-Clinical & CMC Development

Bio-Molecule Manufacturing Capacity

Flexible CMO Solutions for Biologics

  • 500L facilities for tox lots, process transfer, fed-batch, and perfusion

    500L facilities for tox lots, process transfer, fed-batch, and perfusion

    500L facilities for tox lots, process transfer, fed-batch, and perfusion
  • 2000L production for clinical and commercial supply

    2000L production for clinical and commercial supply

    2000L production for clinical and commercial supply
  • Integrated R&D and QC support for seamless tech transfer

    Integrated R&D and QC support for seamless tech transfer

    Integrated R&D and QC support for seamless tech transfer
  • Dedicated ADC manufacturing infrastructure

    Dedicated ADC manufacturing infrastructure

    Dedicated ADC manufacturing infrastructure
  • Fill-finish solutions: aseptic vial, pre-filled syringe, and lyophilized formats

    Fill-finish solutions: aseptic vial, pre-filled syringe, and lyophilized formats

    Fill-finish solutions: aseptic vial, pre-filled syringe, and lyophilized formats

Quality

Quality

Quality Management System

  • Quality Management System

    Quality Management System

    Built on cGMP and ICH standards, our system ensures consistency and compliance across both research and manufacturing.

  • Audit and Compliance

    Audit and Compliance

    Audited over 100 times by clients and agencies; fully aligned with FDA, EU cGMP, and ISO quality standards.

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