What is the difference between Greenfield and Brownfield pharmaceutical projects?
Greenfield projects are entirely new facilities built from the ground up, while Brownfield projects involve upgrading or expanding existing facilities.
What services are included in a turnkey Greenfield FDF project?
We cover complete design, engineering, equipment selection, utility integration, validation, and regulatory compliance for finished dosage form manufacturing plants.
Can you help retrofit our existing API facility for regulatory audits?
Yes. Our Brownfield services include facility revamp, process requalification, documentation alignment, and CAPA support to meet global GMP expectations.
How long does it take to complete a Greenfield project?
Typical timelines range from 12 to 18 months depending on the size and regulatory scope of the facility.
Do you offer end-to-end compliance support with turnkey execution?
Yes. We provide design, engineering, execution, and documentation aligned with WHO-GMP, EU-GMP, and other standards to ensure inspection readiness.
What is the scope of your turnkey pharmaceutical project services?
Our turnkey services cover feasibility studies, facility design, equipment procurement, validation, regulatory compliance, construction, commissioning, and post-handover support for greenfield and brownfield pharmaceutical projects.
How do you ensure GMP compliance in facility design?
We align facility designs with USFDA, EMA, WHO, PIC/S, and Revised Schedule M guidelines, incorporating GMP-compliant cleanroom zoning, HVAC systems, and validation protocols like DQ, IQ, OQ, and PQ.
What is the typical timeline for a greenfield pharmaceutical project?
Timelines vary, but a greenfield project typically takes 12–24 months, depending on facility size, complexity, and regulatory requirements. Brownfield upgrades may take 6–12 months.
How do you support brownfield facility upgrades?
We conduct gap assessments, retrofit designs for GMP compliance, enhance capacity, support tech transfers, and minimize downtime to ensure seamless upgrades.
What industries benefit from your project services?
Pharmaceutical manufacturers, biotech firms, API producers, and CROs benefit from our services, ensuring compliant facilities for finished dosage forms, APIs, and intermediates.
How do you integrate Industry 4.0 into pharmaceutical projects?
We incorporate SCADA, BMS, IoT sensors, eBMR/eBPR systems, and 21 CFR Part 11-compliant solutions to enable real-time monitoring, automation, and data integrity.
