Pharmaceutical Projects

Pre-feasibility to Commercial Production

From Greenfield pharmaceuticals project to Contract Manufacturing JV to IPO — as you make history, we'll be with you every step of the way.

Expert Project Consulting

Our team offers expert guidance on turnkey projects for various pharmaceutical manufacturing processes and technologies.

Tailored Solutions Provided

We deliver tailored solutions for ophthalmic, inhalation, and other pharmaceutical manufacturing needs and requirements.

Our consulting services ensure compliance with industry standards and optimize manufacturing processes for better efficiency.

Regulatory Compliance Support

Projects Life-Cycle

A pharmaceutical turnkey project - from concept to commissioning -delivered as a "ready-to-run" solution. Here's a step-by-step outline of the typical process:

🔹 1. Project Planning & Feasibility

• Market analysis & demand forecasting

• Budget estimation

• Project timeline planning

• Site selection and evaluation

🔹 2. Regulatory & Compliance

• Adherence to GMP, FDA, EU, WHO, or local regulations

• Environmental and safety compliance

• Water Reports

• validation master plan, DQ/IQ/OQ/PQ protocols

🔹 3. Conceptual & Detailed Design

• Facility layout & cleanroom classification (A per FDA guidelines)

• HVAC system planning (airflow, pressure differentials)

• Utility planning (WFI, PW, HVAC, electricals, gases)

• Workflow optimization: personnel, materials, product.

🔹 4. Engineering & Civil Construction

• Soil Testing & Structural Design

• Structural Design

• Architect's Impression.

• Wind and load analysis

• Waterproofing and drainage details

• Integration of HVAC and service ducts if needed

• Safety systems (Evacuation, fire resistance, smoke vents)

• Civil works (flooring, walls, ceiling, drainage)

• HVAC installation

• Electrical and plumbing works

• Cleanroom paneling and infrastructure.

🔹 5. Equipment Supply & Installation

• Procurement of production machinery

• Procurement of Packaging machinery

• Procurement of Testing Lab Equipment

• Utilities (WFI, steam, air compressors)

• Procurement of Accessaries

• Installation and alignment of machines

🔹 6. Validation & Qualification

• Design Qualification (DQ)

• Installation Qualification (IQ)

• Operational Qualification (OQ)

• Performance Qualification (PQ)

• Cleanroom validation, HVAC validation.

🔹 7. Documentation & SOPs

• Preparation of:

  • Batch Manufacturing Records (BMR)

  • SOPs for equipment and facility

  • Calibration & maintenance logs

• Quality manuals and GMP documentation.

🔹 8. HR & Training

• Hire Staff & train on:

  • Administration

  • Accounts & Purchase

  • Production & manufacturing (FDA Approved)

  • Packaging

  • Equipment operation

  • GMP compliance

  • Safety protocols

  • SOP adherence

  • Engineering maintenance

  • QC, QA  (FDA Approved)

  • Documentation

  • IT

  • Stores

  • Sales & Markeing

🔹 9. Trial Production & Test Batches

• Trial runs for each process

• In-process and finished product testing

• Regulatory audits (if needed)

🔹 10. Final Handover & Support

• Full documentation handover

• Regulatory compliance checklist

• Optional post-handover support (Plant Operation for some period, AMC, maintenance, training, expansion etc.)

Strictly followed local FDA guidelines and documentations required for IV fluids, Serum, parenterals and ophthalmic products to ensure successful project execution and compliance.

Manufacturing Excellence

With You -

"From Start-up to Scale."

Contact Us

Get in touch for expert pharmaceutical manufacturing consulting services.