Our Services

01.

Concept to commissioning model

Feasibility and Conceptualisation

  • Market & site feasibility studies.

  • Finalising PFDs.

  • CapEx/Opex & ROI projections.

Detailed Engineering Design

  • PID and Utility layouts.

  • Civil, structural, HVAC & clean-room architecture.

  • Layout optimisation.

Equipment & Instrument sourcing

  • Purchase of equipment, instruments & materials

  • Contract negotiation, expediting & logistics planning

Construction & Installation

  • Civil works: foundations, walls, flooring, utilities.

  • MEP installation (Mechanical, Electrical & Plumbing).

  • Equipment installation.

Commissioning & Qualification

  • Installation Qualification (IQ) & Operational Qualification (OQ)

  • Performance Qualification (PQ) under process conditions

  • Factory Acceptance Tests (FAT) & Site Acceptance Tests (SAT)

Validation & Regulatory Compliance

  • Cleaning, process and method validations per WHO-GMP/FDA.

  • Creation of Validation Master Plan (VMP) and protocols

  • Regulatory filings support (e.g., CEP, D&B dossiers)

Documentation & Handover

  • As-built drawings, equipment manuals & calibration records

  • Standard Operating Procedures (SOPs) & batch records

  • Final “Ready-for-Operation” certificate & handover pack

Training & After-Sales Support

  • On-site operator, maintenance & QA/QC training.

  • Preventive maintenance schedules & spares lists

  • Optional annual service contracts & performance audits

02.

Annual Compliance & Advisory Contract

Project & Technical Advisory

  • Bi-annual audits covering Production, QA/QC, Warehouse.

  • Facilitation of corrective-action plans, root-cause investigations

  • Annual review and revision of SOPs, Master Batch Records and Quality Manuals.

Compliance & Regulatory Support

  • Quarterly progress calls

  • Filings support

  • Two on-site GMP mock audits

  • Preparedness gap analysis.

Training & Talent Development

  • Four on-site or virtual training sessions (e.g., GMP refresher, data integrity, aseptic technique).

  • Seminars for site-management

  • Annual competency assessments

  • Training-gap analysis for key functions.

Raw & Packing Material Sourcing (Integrated)

  • Semi-annual re-qualification audits of your API, excipient & packaging vendors.

  • Bi-annual total landed-cost analyses, duty-drawback advisory.

  • Quarterly forecasts, safety-stock recalibration.

  • Incoming CoA/MSDS review.

  • Vendor corrective-action follow-up.

 Reporting & Governance

  • KPIs on quality metrics, cost-savings (including sourcing-driven savings).
  • Executive-level presentation covering achievements.
  • On-site workshop to align priorities, budgets & growth targets.

Quality Management & Continuous Improvement

  • Bi-annual audits covering Production, QA/QC, Warehouse.

  • Facilitation of corrective-action plans, root-cause investigations

  • Annual review and revision of SOPs, Master Batch Records and Quality
    Manuals

Operations & Supply Chain Optimization

  • End-to-end production cycle time analysis.

  • Annual calibration schedule plus one calibration-support visit.

  • GMP-compliant storage design

  • FIFO/FEFO implementation.

03.

Project Deliverables

  • MIS (Management information system) for every month
  • Monthly Consulting Board meetings
  • Integrated advisory over WhatsApp
  • Documentation Review
  • Minutes of Meeting
  • Monthly Gap analysis audits
  • Motivational and shop floor trainings
  • Monthly Event Calendar