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BioQuality ™   is a provider of innovative, cost effective compliance, regulatory and quality solutions for Life Sciences (Medical Devices, Pharmaceutical and Biotechnology) and Healthcare industries. Some of the key services include Product Development, Implementation/Integration, Project Management, Quality & Compliance, FDA Regulations, Risk Management, Process Improvements, Information Technology (IT) Applications, Testing & QA, Verification & Validation (V&V), Computer Systems Validation (CSV), Training, Audits and Inspections.

BioQuality ™   has industry's best team with vast experience in Medical Devices, Pharmaceutical, Biotech, Healthcare and IT sectors.  Their services will help small to large companies in regulated Life Science industry to reach their quality and regulatory goals more timely and cost-effective manner. These services meet the needs of Healthcare, Medical Devices, Pharmaceuticals – preclinical, clinical, patient care, and manufacturing Quality operations and regulations - FDA 21 CFR Part 210, 211, 58 and 11 and other international (ISO 9000 and ICH) guidelines, and medical devices (cGMP) Quality System Regulations (FDA 21 CFR part 820 and ISO 9001/13485), and 510K, IDE and PMA submissions; and healthcare (HHS) HIPAA and HITECH requirements and SEC’s Sarbanes-Oxley expectations. Also includes FDA regulatory expectations (21 CFR Part 11 and others) of electronics records, data management and IT security in patient care management, drug and medial device development and production processes.

BioQuality ™ has been supporting FDA Remediation and Consent decree projects sucessfully while meeting project Timellines and Complaince !



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