Plant Setup & Projects
From an empty shed to a licensed, running plant
One team handling layout, utilities, equipment selection, documentation and licensing, so the approvals do not arrive six months after the machinery.
- Authority
- Varies with product scope: FSSAI, State Licensing Authority, CDSCO and local bodies
- Governing rules
- Schedule 4 and Schedule IV under the FSS Regulations, Cosmetics Rules 2020, and revised Schedule M as applicable
- Typical timeline
- 6 to 15 months from concept to first commercial batch
Plant Setup Consultancy: what it involves
Most plant projects run into trouble in the same place. Construction is planned by a civil contractor, machinery is chosen by a production head, and licensing is handed to someone else at the end. By the time the regulator visits, the layout has no proper change rooms, the utility room is in the wrong place, and the plant has to be partly rebuilt.
We sequence a project the other way around. The regulatory requirements for your specific products define the layout, the layout defines the civil and utility scope, and the licence application is built as the plant is built. It costs less and finishes sooner than fixing it afterwards.
Who needs this
- First-time manufacturers setting up a new unit
- Brands moving from third-party manufacturing to owned production
- Existing plants adding a new product line or section
- Investors evaluating a manufacturing project before committing capital
- Contract manufacturers expanding capacity or categories
- Units that need to be rebuilt to pass a regulatory inspection
Documentation
Documents required
Arrange these and the file moves. We tell you exactly which format each one has to be in, and we draft the technical annexures ourselves.
- Product list with dosage forms, pack sizes and target capacity
- Site details including plot dimensions, built-up area and utilities available
- Budget envelope and target commissioning date
- Existing drawings, if a building is already in place
- Preferred equipment vendors or an existing machinery list
- Details of the technical team already on board
How we work
The process, stage by stage
Indicative durations for a file where documents arrive on time. We tell you at the outset which stage is most likely to slip in your case.
- 1
Scope definition and feasibility
2 to 4 weeksWe convert your product list and capacity target into a regulatory scope, an area requirement, a utility load and an indicative capital budget. This is the point at which a project is either viable or should be reshaped.
- 2
Layout and engineering design
4 to 8 weeksCivil, HVAC, electrical, plumbing and equipment general arrangement drawings are prepared against the licensing requirements for your products.
- 3
Equipment specification and vendor support
3 to 6 weeksWe specify machinery and utilities, review vendor quotations technically rather than only commercially, and check that what is being bought will qualify.
- 4
Documentation and licence filing
Parallel workstreamThe quality system, SOPs and licence applications are prepared while construction proceeds, so filing happens the moment the site is ready.
- 5
Commissioning, inspection and handover
4 to 10 weeksWe support qualification and validation, prepare the team for inspection, close observations and stay on until the licence is granted and the first commercial batch is released.
Questions
Frequently asked questions
Can you work with our existing architect and contractor?
Yes, and that is the usual arrangement. We define what the regulator requires and review their drawings against it. They keep building; we make sure what gets built will be licensable.
How much area does a nutraceutical plant need?
It depends entirely on dosage forms and capacity. A single dosage form pilot unit and a multi-form commercial plant differ by an order of magnitude. We size it properly at the feasibility stage rather than quoting a number that would be meaningless without your product list.
Do you take responsibility for getting the licence?
We take responsibility for the filing, the documentation and the inspection preparation, and we stay on the file until it is decided. No consultant can guarantee a regulator's decision, and you should be cautious of anyone who does.
What is the biggest avoidable cost in a plant project?
Rework. Rebuilding change rooms, relocating a utility room or re-routing material flow after an inspection observation typically costs several times what it would have cost to design correctly at the start.
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Often taken together with this
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