Building a nutraceutical or health-supplement manufacturing facility from the ground up is where most projects lose time and money. A layout that fails GMP flow, a licence class filed wrong, a quality-control lab that has to be rebuilt after the first inspection: each of these is expensive precisely because it is discovered late. A greenfield plant is a regulatory project as much as a construction one.
We take your project from an empty site to a licensed, inspection-ready plant: the regulatory pathway, a GMP-compliant layout, the documentation system, and your FSSAI manufacturing licence, handled by practitioners who know how the regulator actually reads a facility.
Who is this service for?
- Founders launching an own-manufacturing nutraceutical or supplement brand
- Food companies adding a dedicated nutraceutical manufacturing line
- Contract manufacturers scaling to a dedicated GMP facility
- Businesses whose architect-drawn layout needs a regulatory and GMP review before construction
What is included?
- Feasibility and regulatory pathway: product-category mapping and a documented approval roadmap
- GMP-compliant plant layout: flow of people, material and waste, and zone segregation to Schedule IV
- Utilities and environment specification: HVAC, air handling, water system and hygiene zones
- Documentation system: GMP manual, SOPs, batch records, cleaning and quality-control specifications
- FSSAI Central manufacturing licence filing on FoSCoS and allied registrations
How does the process work?
- 1Discovery and feasibility review of product, scale and site
- 2Regulatory and GMP design brief issued
- 3Layout, utilities and documentation development
- 4Licensing and construction-stage compliance support
- 5Commissioning, mock audit and licence grant
Which documents will you need?
- Intended product list and target manufacturing scale
- Site plan or available premises details
- Any existing architectural or utility drawings
- Company constitution and KYC for licensing
How long does it take?
Brief within a few weeks
A feasibility and GMP design brief is typically issued within a few weeks of the scoping review. Overall project duration depends on scale, site and construction, so we set a milestone timeline up front and run licensing and build in parallel rather than in sequence.
How long is it valid?
The FSSAI manufacturing licence the project delivers is issued for the period you elect, from one to five years, and is renewed before expiry. The Schedule IV GMP systems behind it are a continuing obligation, not a one-time clearance.
Common mistakes we correct
- Designing the building first and forcing GMP flow into it afterwards
- Filing the wrong FSSAI licence class for the intended activity and capacity
- Quality-control lab and warehouse space planned as an afterthought
- Utilities and hygiene zones specified below what the product category requires
Frequently Asked Questions
Do you set up nutraceutical plants across India?
Yes. We handle greenfield projects nationwide, with regulatory and GMP design coordinated remotely and on-site involvement at the key milestones such as layout finalisation, pre-inspection walkthrough and the FSSAI inspection itself.
What GMP standard must a nutraceutical plant meet?
Manufacturing must meet the Good Manufacturing and Hygiene Practices set out in Schedule IV of the FSS (Licensing and Registration) Regulations, 2011, alongside the product-category requirements of the Health Supplements and Nutraceuticals Regulations. The GMP requirement shapes the layout, so it belongs in the design stage, not the inspection stage.
Can you review a layout our architect has already drawn?
Yes. A GMP design review catches flow, segregation, lab and utility risks while they are still lines on a drawing, which is far cheaper than discovering them after the walls are up or at inspection.
Regulations that apply
- FSS (Licensing and Registration of Food Businesses) Regulations, 2011: Schedule IV GMP/GHP
- FSS (Health Supplements, Nutraceuticals…) Regulations: manufacturing and product requirements
- FoSCoS portal (foscos.fssai.gov.in): manufacturing licence filing