Driving Pharmaceutical Innovations through Expert Research Partnerships



We are committed to delivering innovative solutions for biopharmaceutical development. With a focus on quality, reliability, and efficiency, we aim to support our clients in advancing their biopharmaceutical products from concept to commercialization. Our state-of-the-art facilities and experienced team enable us to offer a wide range of services, including central lab services with fully customizable advanced testing strategies, clinical trial design and regulatory consulting.

Central lab services
Histopathology & Digital Pathology
  • We provide a wide range of IHC-based biomarker testing services from a selection of validated assays, to customized assays including antibody selection and validation, to the proper (selection) of control tissues from our large biopsy tissues repository.

Platforms IHC test menu:
Leica Bond Rx & Bond III
Roche Ventana
BenchMark ULTRA​
Agilent Dako
Autostainer 48
FLX® IHC System​
Varistain Gemini
Digital Pathology
We offer full digital pathology services with our DigitCells-powered Image Management System, enhancing pathologists' skills and improving data delivery and collaboration. GoPath Biopharma's AI-driven spatial pathology image processing boosts diagnostic capabilities, aiding clinicians in making better-informed decisions in precision medicine.
Molecular Pathology
  • With our innovative and diverse genomic capabilities combined with our problem-solving skills, GoPath Biopharma team is skilled to deliver a complete set of streamlined testing solutions and new assay design and validation services, using high-throughput technology to serve both emerging biotech and large pharmaceutical companies.

    With the most up-to-date technologies in gene expression, genotyping and next generation sequencing, our scientists will design the optimal assays on cutting-edge platforms, meeting all your requirements for both pre-clinical and clinical studies or nonclinical studies.

Digital PCR
Sanger sequencing
Next-Generation Sequencing
GoPath offers a wide variety of individual probes and panels to complement the study's workup, as well as custom probes tailored to specific end-goals.
Biocare Oncore Pro

Cytogenetics (Karyotyping)

Chromosome analysis, or karyotyping, involves analyzing the number and structure of chromosomes to detect abnormalities. A live cell sample is collected and cultured to promote cell division. The cell cycle is arrested in metaphase, and the isolated chromosomes are placed on a slide and stained. Each chromosome has a unique fingerprint, and they are mapped and examined for changes in number and arrangement. Karyotyping looks for gross structural abnormalities in the DNA and is essential for the proper diagnosis of acute leukemias and myelodysplastic syndromes.


  • GoPath Biopharma offers full-service flow cytometry services whether using CLIA-validated test panels or study-specific biomarker assay development, including discovery and validation, whether for clinical studies or precision medicine (targeted therapy).
Beckman Coulter Navios

Companion Diagnostics (CDx)

As an integral part of precision medicine, CDx allows scientific investigators and clinicians during clinical trials to:
  • Prescreen candidates to select those who would most likely benefit from therapy

  • Monitor their response
    to treatment either
    for dosage adjustment
    or discontinuation
  • Achieve drug safety while reducing development time
    and cost

Whether your CDx goal necessitates in-house laboratory developed test or FDA-approved in vitro diagnostic test, our Biopharma team provides full-service assay development to reach your objectives.

  • Biomarker identification

    & development

  • Assay development

    and validation

  • Regulatory guidance: Premarket Approval (PMA) application development and submission

Specimen management & Kit design

Transport, storage and optimal sample handling are critical steps for the preservation of the sample's quality and integrity necessary for cutting-edge technology testings in maximizing data insight.

Biospecimen Management

Our global processing shipment and logistics services include the following:

  • Follow the sample from collection to analysis

  • Custom kit assembly

  • Optimized shipment operations

Our biorepository can store fluid and solid specimens at controlled ambient temperatures, +4°C, -20°C,

and -80°C, and includes numerous security and safety features:

  • Dedicated back-up units

  • Around-the-clock automated temperature monitoring

  • Sample accessioning for all sample types: 5-day TAT approx

Clinical trial management and regulatory consulting​
We've partnered with GenReq, a Regulatory Affairs, Clinical Research, Medical Affairs and Safety consulting firm with extensive experience in order to provide our clients with an integrated business solutions to license, import, distribute, manufacture and/or market healthcare products globally including US, Canada, China and EU.

From testing to approval, we ensure your regulatory pathway will be successful.

  • IVD devices
    Molecular Diagnostics, Companion Dx, COVID-19 PCR, Antibody or Antigen Test, Digital Scanners, and Lab Validation​
  • Medical Devices
    510(k)s, PMA, Q-Sub, EUA​
  • Drugs
    FDA meetings, Pre-IND, EOP2, Accelerated Programs, IND preparation and review (CMC, Nonclinical, Clinical), NDA preparation, DMF preparation, Safety Monitoring, Communication with Agency (Responses to Warning Letters and Inquires)​
  • Clinical Trials
    Protocol design consulting and writing for laboratory logistics and science​
Meet Our Team
Quality Management
  • A Quality Management System (QMS) is the cornerstone of a contract research laboratory's ability to consistently provide services that meet customer and regulatory requirements. We have set up a highly structured system of processes aimed at ensuring the quality and integrity of the laboratory's output, encompassing all aspects of our operations, from sample receipt and testing to data analysis, reporting, and archiving. We strive to achieve customer satisfaction and continuous improvement in all aspects of our performance.

    To support this, we rely on a broad Quality Control (QC) and Quality Assurance (QA) program, supported by a robust document control system, and regular competency assessments and trainings for our employees.

Hire and train qualified personnel
Operate and maintain compliant facilities
Calibrate, validate and maintain laboratory instruments
Label and store efficient reagents and specimens
Validate methods and monitor processes performance
and record all activities
Write, authorize and organize detailed SOPs
Plan for secured documents archive
Exceed laboratory and data management requirements
Schedule internal and external audits
Empowering Your Drug Development Journey: ​
Our Solutions
Clinical Trials
Phase I
Phase II
Phase III
Post-market and Phase IV
Precision Medicine and Companion Diagnostics Commercialization
IVD and Biopharma Specialty Lab Services
Data analytics
Life Cycle Management​
Clinical Trials​
Precision Medicine and Companion Diagnostics Commercialization
  • Clinical trial specialty testing support
  • Assay development and validation
  • Specialized biomarker testing
  • Evaluation of drug efficacy
  • Project and data management services
  • Kitting services
IVD and Biopharma Specialty Lab Services
  • Method development
  • Analytical testing 510 (k) and PMA CAP/CLIA testing services
  • Postapproval studies
  • Biorepository services
  • End-to-end solutions
  • Pre-launch medical communications and proficiency paring
  • Commercial testing
  • Assay development, validation, and scale-up
  • Sponsored testing and REMS programs
Data analytics
  • Prevalence
  • Competitive landscape
  • Demographics
  • Comorbidity conditions
  • Biomarker/CDx development by region and/or population
Life Cycle Management​
  • Recommended changes
  • Competitive response and performance
  • Real-world and post-commercialization
Clinical Trials​
  • Site/PI validation and identification
  • Confirmed patient population
  • Patient engagement and enrollment
  • Physician validation and outreach

Biopharma and Medical Device Partners

Accelerate your biopharma success

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