Design · Procure · Build · Qualify · Comply · Operate
We build it. We maintain it. We support you through every inspection.
APSRR is a single turnkey partner for pharmaceutical facilities — one contract from the first drawing through regulatory licensing to the maintenance, requalification and spare support that keep the plant compliant for its entire life. No handoffs between contractors, vendors and consultants.
Everything, under one roof
One contract. Three commitments.
Wherever your facility is in its life, it falls under one of three things we're on the hook for.
01
Build
Design, procurement, construction and qualification — one site team from first drawing to signed certificate.
02
Maintain
Preventive and corrective maintenance, HVAC requalification and instrument calibration, scheduled before anything's due.
03
Support
Facility licensing, inspection readiness, spare parts and staffing — the backup that's still there after we leave site.
One point of accountability
One contract and one team, so nothing falls into the gap between contractors.
No vendor handoffs
The team that designs the room is the team that qualifies and maintains it.
Documentation from day one
As-builts, SOPs and certificates start at kickoff, not after a scramble at handover.
Still on call after handover
Maintenance, requalification and regulatory support don't end at the ribbon-cutting.
What we do
One contract, from first drawing to renewed license.
Design, procurement, construction, qualification, regulatory compliance and ongoing operations — run by one team so nothing gets lost at the handoffs.
Stage 01
We start with a requirement, not a floor plan.
A site walk, your process flow and target ISO class turn into a room-by-room specification and airflow scheme — the document everything downstream gets built against.
Facility & process design
Architecture, process flow and mass balance for the whole facility, not just classified rooms.
MEP & utility engineering
HVAC master plan, electrical, plumbing, purified water and gas systems, engineered together.
Cleanroom & airflow scheme
ISO classification, pressure cascade and air-change rates for every classified space.
Stage 02
One procurement team, so nothing gets stuck between vendors.
Process equipment, cleanroom systems and utility plant, sourced, vendor-qualified and scheduled against the build — not left for you to chase separately.
Process equipment
Vessels, filling lines, washers, depyrogenation tunnels and autoclaves, specified to your process.
Cleanroom & utility systems
Panels, AHUs, gas generation and purified water skids, matched to the design.
Vendor qualification & FAT
Supplier audits and factory acceptance testing coordinated before anything ships.
Stage 03
Panels go up, systems come online, and the room gets its first balance.
Civil works, cleanroom fit-out, MEP and equipment installation — one site team, start to finish, to the approved drawings.
Civil & structural
Shell, slab and structural work for new-build or retrofit facilities.
Fit-out
Panels, ceilings, doors, coving and flooring installed to the approved drawings.
MEP & equipment installation
AHUs, ducting, utilities and process equipment set and connected.
Commissioning
Balancing, controls, leak checks and snag closure before qualification opens.
Wall and ceiling systems
Modular panels, walkable ceilings, flush view panels and coved corners throughout.
Doors and pass-throughs
Interlocked doors, dynamic and static pass boxes, airlocks and gowning sequences.
Flooring and finishes
Epoxy and vinyl systems, coving, sealed penetrations, cleanable surfaces.
Utilities and piping
Purified water loops, compressed air, dust extraction, drains and gas lines.
Stage 04
Every test, with the number it has to hit.
Room, HVAC and equipment qualification, process validation and instrument calibration — executed to written protocol and reported with raw data, calibration certificates and a signed summary within five working days.
HEPA filter integrity
HVAC system qualification
Airflow velocity and air changes
Non-viable particle count
Room pressure balancing
Temperature and humidity mapping
Recovery and cleanup rate
Airflow visualisation
Instrument calibration
Equipment IQ/OQ
Process validation
Light, sound and UV intensity
Stage 05
A facility that's built right still needs a license to run.
Facility registration, GMP licensing, SOPs and inspection readiness — built alongside the construction schedule so compliance isn't a scramble after handover.
Facility registration & licensing
FDA establishment registration, state board licensing and GMP certification support.
SOPs & documentation systems
Master SOPs, batch record design and electronic documentation systems, set up and trained on.
Inspection readiness
Gap assessments, mock audits and CAPA support ahead of a real regulatory inspection.
Stage 06
Certified, documented, and still on call after we leave.
As-builts and certificates at handover — plus maintenance, periodic qualification, spares and regulatory support, so the facility stays in spec and in compliance for the long run.
As-built documentation
Drawings, turnover packages and a room-by-room certificate set.
Staffing & training
Operator and GMP training programs to bring your team up to spec on day one.
Maintenance
Corrective service on cleanroom systems, HVAC and process equipment when something needs fixing.
Preventive maintenance
Scheduled PM programs for AHUs, terminal filters and utilities, so breakdowns are the exception.
Periodic qualifications
Scheduled requalification and internal audits, tracked and executed before they're due.
HVAC requalification
Periodic re-testing of AHUs and airflow systems to keep the original qualification current.
Calibrations
Scheduled recalibration of gauges, sensors and loggers, tracked against due dates.
Spare support
Critical spares for filters, gauges, loggers and process equipment, stocked and ready to ship.
Regulatory support
License renewals, change control filings and inspection support once the facility is operating.
Get in touch
Tell us what you're building, licensing or operating.
Room count and grades are enough for a first number on construction. For design, regulatory or ongoing support, a short scope note is enough to start.
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