GLOBAL EXPERTISE IN QUALITY MANAGEMENT, DIGITAL HEALTH AND BIOMEDICAL INNOVATION
Quality Management
Our team can help your company attain or maintain GxP readiness, provide training and build Quality by Design program
GxP audits (CROs, CMOs, CDMOs, Central Labs, Pathological Labs, PK Labs, Specialised Labs, Imaging Labs, Raters, Data Centres, TMF and eDC providers, Investigator Sites, TMF audits, CSR audits , Packaging and Labeling, IRT, CSV and more)
Inspection Readiness Gap Assessment, Mitigation and Remediation Programs
Training on ICH, PIC/s, CFRs, US FDA Guidance Documents, Inspection Checklists, etc.
QMS revamp or designing including SOP write-ups (we have a bank of over 200 SOPs for various stage companies and can provide ready-to-use material to kick start the QMS)
We can assist you in providing latest Biomedical health equipment solutions
Rapid Biological Indicators (20 minutes, 60 minutes, 180 minutes) for steam, ETO and Formaldehyde sterilisation
One of the leading biomedical equipment providers in Canada and the US (sole agents of Mazree LLC) with special focus on Lithotripters, Imaging equipment (MRI and CT scanners, Ultrasounds, X rays), Cyber knife, Cardiac ablation catheters and more
Building and/or providing cutting-edge state-of-the-art digital health applications for Clinical Research, Real World Evidence, Hospital and Home Care providers
AI-based symptom checker (over 90% proven accuracy) and registered with MHRA (Class I)
Telehealth (VoIP) solution
IoMT (integrated for real-time patient monitoring)
