Now,
BioQuality is not soliciting business
that includes consulting & recruiting services
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.
|