Capabilities ยท 03
Quality, Documentation & Regulatory
A plant that cannot be inspected cannot sell anything. The documentation set is engineered with the same seriousness as the building.
The Real Differentiator
Most turnkey contractors deliver steel and leave the paperwork to the client.
That is where projects stall. The building is finished, the equipment is installed, and the plant then sits idle for months while somebody works out what the quality system should have said all along. We treat the documentation as part of the deliverable, because it is the part that determines whether the facility can be licensed.
Quality Scope
What we build alongside the plant.
- 01
Documentation from day one
The quality documentation set is developed in parallel with construction rather than retrofitted at the end. By the time the plant is mechanically complete, the paperwork that makes it licensable already exists.
- 02
Quality management system
QMS structure and full standard operating procedure suites across production, quality, engineering, stores and utilities: the procedures the plant is actually run by.
- 03
Laboratories
Quality control and microbiology laboratory design and equipment, and analytical method transfer so the lab can release product from the day it opens.
- 04
Validation
Validation master plan, process validation, cleaning validation, computerised system validation and utility qualification, executed and documented.
- 05
Inspection readiness
Documentation prepared to WHO-GMP standard and structured for regulatory inspection, so an auditor's request is answered from the file rather than reconstructed.
- 06
Dossier and CTD compilation, in house
Product registration dossiers compiled internally, backed by a dedicated regulatory affairs director. This is unusual for an execution contractor to hold, and it is the difference between a finished building and a licensed product.
Regulatory capability held in house, not subcontracted.
Dossier and CTD compilation sits inside the company under a dedicated regulatory affairs director. That means the registration strategy for the target market can shape the plant while it is still on paper, rather than being discovered as a constraint after commissioning.
Planning a pharmaceutical facility?
Tell us the dosage platforms you are considering, the market you are registering in and the status of your site. We will tell you what the project actually involves.