What We Do ...

BioQuality Inc. 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), Qualification, Computer Systems Validation (CSV), GxP Compliance, Training, Audits and Inspections.

BioQuality  Inc. has industry's best team with deep experience in Engineering; especially in HVAC (heating, ventilation, and air conditioning) services for manufacturing facilities in Pharmaceutical and biotech industries. Our 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.  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 medical device development and production processes.

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