Together, these affiliated companies collaborate to deliver integrated, high-quality solutions across pharmaceutical engineering, validation, and quality assurance.
Validation & Qualification Services
Commissioning & qualification of facilities, utilities, and process-controlled equipment
Process validation, including documentation development for Bulk and Filling process
C&Q of HVAC systems, BMS system, water purification, DI, WFI, clean & plant steam, cleanrooms, and environmental systems
Comprehensive cleaning validation (riboflavin testing, swabbing, sampling, cycle verification) for tanks (Multi use and single use), bioreactors, chromatography column, vessel, passive/active Rabs, isolators, autoclaves, washers
Temperature mapping and environmental monitoring program for clean room, cold rooms, and freezers
Engineering & Process Optimization
Development of user requirements (URS), hardware/software design specifications, and functional design documentation
Engineering studies for product shipments, environmental impacts, and shipment excursions with data-driven reporting
Value stream mapping across manufacturing, from receiving to final product shipment
Yield investigations, process improvements, and cost-reduction strategies
Implementation of risk-based validation, significantly reducing study loads and cleaning cycle times
Gap assessments and remediation strategies for utility systems, validation states, data integrity (including ERES), and visual inspection programs
Development of project validation plans, SOPs, training modules, and technical documentation
Technical leadership for technology transfers, reformulations, and registrations in domestic and global markets
Application of structured problem-solving tools (Kepner-Tregoe, Ishikawa/Fishbone analyses)
Engineering Startup Support for New Facilities
Commissioning and qualification of new process equipment, utilities, and infrastructure
Walkdowns and updates of P&IDs, drawings, and documentation for process skids and support utilities
Development of start-up project plans, engineering test procedures, and change control coordination
Recommendations and support to ensure seamless cGMP-compliant startup operations and an achievable validation estate
Implementation of preventative maintenance systems, spare parts inventory programs, and training systems
Regulatory & Quality Assurance Services
Comprehensive assessments of project execution gaps, compliance issues, and CAPA strategies
Direct interfacing with regulatory agencies (e.g., FDA) to address validation and compliance queries
Auditing and remediation of validation packages, technical investigations, and batch documentation
Support for government inspections, supervisory training programs, and safety compliance initiatives
