Consultancy for startup in Asia
Support new company startup in areas of pharmaceutical manufacturing and services, including market analysis, business conceptualisation, modelling as well as operational design and setup
Services
Equipment selection, sourcing & commissioning
Understand user requirement, create URS, select best equipments keeping in mind URS and budget and installation support.
Instrument calibration requirement studies and procedural setup
Give necessary recommendations for calibration of instruments and setting procedure guidelines.
Customized Solution for Process Automation using PLC & SCADA systems
Assess individual systems for customised solution requirement and develop solution using PLC and SCADA.
Gap Analysis and Process improvement studies
Study process requirements and analyse automation gaps and recommend steps for improvement.
Automation implementation according to Pharma 4.0
Study and recommend/implement layers of automation (DCS, MES, ERP) for available and new set up according to budget and feasibility.
EMS and BMS consultation
Selection, budget, and commissioning support.
GAMP 5, CSV, 21 CFR compliance
Recommendation, implementation and validation, FAT, IQ, OQ, CSV and documentation with respect to GAMP 5 and FDA requirement.
Process Recipe creation and test validation
Analyse user requirement and equipment to generate various recipes and validate the same (eg. MAbs)