Our Services

BioAccurate provides the following services:

Conducts the most specialized GLP | GCP | GCLP | CLIA-compliant bioanalysis, biomarker, immunotherapeutics, NGS or Central labs study audits

Audis GLP | GCP | CLIA clinical and pre-clinical facilities and central labs to ensure compliance according to the FDA | OECD | EMA | MHRA | ICH | CLIA | NMPA regulations and guidelines

Conducts the most GCP and GLP Laboratory/facility qualifications

Manages and monitors bioanalytical and biomarker study outsourcing (clinical and preclinical) and provides project management support for GLP, GCP and animal health programs on behalf of the sponsor

Conducts the unparalleled quality process, SOP, and facility and laboratory gap analyses, and provides respective laboratory and process improvement consulting

Conducts mock-FDA inspection, training, remediation and CAPA support and study pre-submission review

Trains regulatory and scientific staff on the regulatory expectations and industry policies and practices associated with a bioanalytical and biomarker laboratory (small and macromolecule analyses)

Applies innovative solutions to the method development and validation/ qualification of bioanalytical or biomarker methods for applications to human and animal drug development

Consults on Large/Small Molecule drug attrition processes in the GLP lab

Evaluates analytical data and associated reports; including raw data chromatography, response data, and the statistical data relevant to ensure compliance

Prepares analytical reports and procedures

Prepares biotechnical due diligence reports that provides technical insights, including biotechnology pipeline SWOTs and market risks