BioQuality ™   is a provider of innovative digital transformation, cost effective compliance, regulatory and quality Consulting Solutions for Life Sciences (Medical Devices, Pharmaceutical and Biotechnology) and Healthcare industries. Some of the key services include Business Operations, Business Development, Project Management, Product Development, IT Apps Implementation/Integration, , Quality & Compliance, FDA Regulations, Risk Management, Process Improvements, Cloud Technology for IT Infrastructure Applications, Testing & QA, Verification & Validation (V&V), Quallification, Computer Systems Validation (CSV), GxP Complaince, 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 accomplish their digital transformations and compliance goals more timely and cost-effective manner. These services meet the needs of Healthcare, Medical Devices, Pharmaceuticals – preclinical, clinical, patient safety, product development, 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 applications or product cybersecurity in patient care management, drug and medial device development and production processes.

BioQuality ™ has been providing these Consulting Services sucessfully with high credibility for over a decade !