BioAccurate Consulting can support your team with its bioanalytical needs, including general QA support services, GLP facility and study directed audits and methods development and/or validation projects from design to laboratory assistance to complete project management. A specialist in facility and data-directed auditing, BioAccurate delivers the most comprehensive auditing service and strategic audit consulting available, as part of its ability to support your QA team and analytical initiatives. BioAccurate leverages it bioanalytical science and regulatory experience, especially associated with methods validation in mass spectrometry, DDI and LBA to support QA in support services, including: GLP and bioanalytical training, site inspections, data and final report reviews, CAPA, GAP analysis, technical and SOP writing, FDA remediation support as well as process improvement.
In an industry experiencing perpetual advancements in analytical technologies and electronic data management, the integrity of electronic source data, and Part 11 compliance has become as essential of an aspect of bioanalytical methods development and study projects, for FDA regulatory approval. By integrating [an expert] current scientific expertise associated with its mass spectrometry and immunoassay method development and validation services, BioAccurate is positioned to ensure raw data integrity as well as the regulatory compliance processes expected by the FDA and other agencies. Partnering with an expert that proves the leading QA training for raw data review, and a specialist in bioanalytical methods development and validation consulting and management, Part 11 compliance (data integrity) is ensured with BioAccurate, despite the analytical technology utilized.
BioAccurate can identify the right method development strategies to ensure method robustness, speed and run success during sample analysis, rapid and compliance methods development, and assurance of FDA compliance and data integrity. Your team can reduce the significant costs associated with internal project planning and/or methods development, validation and analytical outsourcing by partnering with a bioanalytical consultant that has a history of delivering timely results, high quality analytical methods and QA support. BioAccurate ensures method development and analytical project success through comprehensive study/site plans that are structured for appending to protocols and/or contracts, as well as establishing laboratory and project expectations, up front. Project and data monitoring is supplemented with unsurpassed experience in bioanalytical project management and analytical laboratory procedures at the highest level in the consulting industry.
Our primary motivation lies in helping you advance your bioanalytical goals, whether by supporting your QA staff, providing an additional expert in the bioanalytical lab, or managing the outsourcing of your bioanalytical projects with guaranteed success. BioAccurate Consulting can partner with you to meet any of the following bioanalytical compliance support:
- Outsourcing Bioanalytical Studies
- Mass Spectrometry
- LBA / Immunoassays
- Biomarker Studies
- Method Development
- Method Validation
- Process Efficiency Consulting
- Data Audits and Monitoring
- Quality Assurance
- Compliance Process Consultancy
- Study Director / Study Monitor
- Remediation Support
- GLP Toxicology in Life Inspections