Collaborate.Innovate.
Advance.
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.
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.
BenchMark ULTRA
Autostainer 48
FLX® IHC System
Access digital biobanks for research and pharmaceutical studies:
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.
TEST MENU
Cytogenetics (Karyotyping)
Hematopathology
- 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).
Companion Diagnostics (CDx)
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
From testing to approval, we ensure your regulatory pathway will be successful.
IVD devicesMolecular Diagnostics, Companion Dx, COVID-19 PCR, Antibody or Antigen Test, Digital Scanners, and Lab Validation
Medical Devices510(k)s, PMA, Q-Sub, EUA
DrugsFDA 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 TrialsProtocol design consulting and writing for laboratory logistics and science
- 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.
and record all activities
Our Solutions
- Clinical trial specialty testing support
- Assay development and validation
- Specialized biomarker testing
- Evaluation of drug efficacy
- Project and data management services
- Kitting 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
- Prevalence
- Competitive landscape
- Demographics
- Comorbidity conditions
- Biomarker/CDx development by region and/or population
- Recommended changes
- Competitive response and performance
- Real-world and post-commercialization
- 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