Toxicological Risk Assessment
- Toxicological Risk Assessment of Medical Devices
- ADE/PDE/OEL & OEB Calculations
- Genotoxic Evaluation (ICH Q3A/B/C, M7)
- Training on Cleaning Validation
- Safety Assessment Reports
- Preparation of MSDS/SDS
GMP Approvals & Inspections
- Support for EU-GMP, USFDA, WHO, TGA, ANVISA, GCC, COFEPRIS
- Vendor Assessment Audits
- Plant Layout, Equipment, Infrastructure, Flow of Man & Material
- Validation, Calibration & Qualification
- CAPA, Risk Management, GAP Assessment (Schedule M)
Greenfield / Brownfield Projects
- Green field, Brown Field, Sterile, OSD, Liquid orals Biosimilar and MABs.
- API & Intermediates facilities
- Complete plant setup from initial planning to commercialization
Calibration Lab (NABL Accredited)
- Thermal: Temperature & Relative Humidity (RH), IR Thermometers, Furnace, Oven
- Electro Technical: AC/DC Current, Voltage, Resistance, Inductance, Time, Frequency
- Mechanical: Dimension, Speed & Acoustics, Length etc.
- Pressure/Vacuum: Pressure/Vacuum/Magnehelic Gauges, Transmitters, Safety Valves
- Mass & Volume: Weights, Weighing Balance, Pipettes, Burettes
- Others: pH Meters, ORP, Conductivity Meters, TDS, Flow Meter
Regulatory Compliance & Device Registration
- CTD/ACTD dossier preparation & submission
- Medical Device Filing (Class A–D, CDSCO MDR-17)
- CEP/DMF submissions (EDQM, FDA, Health Canada)
- Clinical/Non-Clinical overview, Bio Waiver Prep
- Managing regulatory responses & remediation
- MAH Representation, QP, Batch release for Europe
Validation (CSV / Equipment / HVAC)
- Lab Systems (HPLC/GC/UV/FTIR etc.)
- Process Automation Systems (PLC/SCADA/IPC)
- Environmental Monitoring Systems (EMS)
- Enterprise Apps (ERP/LIMS/DMS/QMS etc.)
- Temperature Mapping (SIP, Autoclave, Tunnel, Warehouse)
- HVAC Validation (DOP, Air Velocity, Filter Integrity)
Technology Transfer
- R&D to GMP site transfer
- Formulation development & transfer
- Know-how transfer (1800+ products)
- Analytical Method Development & Validation
Third Party Services
- All types Of the medical devices
- Manufacturing partnerships for OSD ,Sterile formulations, Liquid Orals, Biosimilars & MABs
- Placement services in Pharmaceutical industry
GMP Approvals & Inspections:- We have experienced EU -QP to perform the GAP assessment and Pre-audits.
- Support for EU-GMP, USFDA, WHO, TGA, ANVISA, GCC, COFEPRIS
- Vendor Assessment Audits
- Plant layout, equipment, infrastructure, and flow of man & material
- Validation, calibration & qualification
- CAPA, risk management & GAP assessment (Schedule M)
AI-Driven Quality & Compliance
- AI-Based Deviation Management: Smart detection, classification & trending with automated root cause and impact analysis
- AI-Enabled CAPA Management: Intelligent recommendations, effectiveness tracking & risk-based prioritization
- AI-Powered Investigation Support: Automated RCA, data correlation & faster investigation reporting
- AI-Assisted BMR/BPR Review: Automated batch record checks for errors, missing entries & compliance
- AI-Based SOP Creation: Fast drafting, review & alignment with EU GMP, USFDA & WHO standards
- Predictive Quality Analytics: Early risk detection using trends from deviations, OOS & process data
- AI-Driven Audit Readiness: Real-time compliance monitoring & automated audit gap identification
