Stage 01
We design and build the plant
GMP facility layouts, material and personnel flow, HVAC and cleanrooms, purified water, WFI and clean steam. One team from the first drawing to commissioning, so nothing falls between six vendors.
Now enforceable Revised Schedule M applies to every licensed manufacturer
Your plant has to pass. We make sure it does.
Pharmateq designs, upgrades, documents, and validates pharmaceutical facilities across India, from an empty plot to an approved plant. Then we stay for up to five years to keep you compliant.
- Revised Schedule M
- WHO-GMP
- EU-GMP
- US FDA
- Ahmedabad, Gujarat
Pressure cascade / airlock sequence / classified zones
- 45+ Plants designed and commissioned
- 180+ GMP audits conducted
- 3,200+ Documents prepared
- 60+ Years combined experience
- WHO-GMP
- Revised Schedule M
- EU-GMP
- US FDA
- PIC/S
- CDSCO
- FDCA Gujarat
The Schedule M deadline
The deadline moved. Then it stopped moving.
Revised Schedule M is now enforceable. Thousands of manufacturing units across India still have gaps in HVAC, water systems, documentation, or qualification, and the cost of fixing them properly is quoted in crores.
Here's what most consultants won't tell you: you probably don't need to spend all of it.
A large share of the cost in a typical upgrade quote comes from over-engineering: specifying equipment beyond what your product category and your regulator actually require. We start every engagement by separating what is mandatory from what is optional, in writing, before you commit a rupee.
HVAC and air handling ₹1.8 cr
Water and clean steam ₹1.4 cr
Qualification and validation ₹0.9 cr
QMS and documentation ₹0.5 cr
Over-specified equipment ₹4.1 cr
Deferrable civil scope ₹3.3 cr
- Mandatory now: ₹4.6 cr
- Deferrable: ₹7.4 cr
Illustrative only. Every plant differs. Your split comes from your gap report.
What we do
From an empty plot to permanent compliance.
Stage 02
We prove it holds up
Gap assessments against every clause, mock audits, DQ/IQ/OQ/PQ, process and cleaning validation, CSV and data integrity. Written evidence an inspector will accept, not a verbal assurance.
Stage 03
We keep it compliant
Revised Schedule M and WHO-GMP upgradation, PQS and SOPs, FDCA and CDSCO licensing, and training with effectiveness checks. Weekly or monthly visits for up to five years.
- Plant Design & Turnkey
- GMP Compliance & Upgradation
- Audits & Inspection Readiness
- Documentation & QMS
- Qualification & Validation
- Training
- Regulatory & Licensing
Why Pharmateq
Compliance is not a certificate. It is a habit.
Most consultants hand you a binder and a bill. Six months later the SOPs are out of date, the trained staff have left, and the next inspection finds the same gaps.
Concept to completion
Layout, workflow, HVAC, cleanrooms, purified water, WFI, clean steam, URS, detailed engineering. One team from the first drawing to the final approval, with no coordination gaps between six vendors.
Minimum justified expense
We separate what the regulation requires from what a vendor wants to sell you. Our upgradation plans are built around the least expensive route to genuine compliance, not the most profitable one.
Five years, not five weeks
Weekly or monthly site visits. Live documentation updates. Ongoing training with effectiveness checks. Manpower support. We stay until compliance is a habit, not a project.
How we work
We start with the gap, not the invoice.
Four stages, realistic timelines, and a written deliverable at the end of each one. You always know what you are paying for and what you are getting.
1
Gap assessment
We inspect your facility against every applicable clause and hand you a prioritised, written gap report: Critical, Major, Minor. Not a verbal opinion.
2-4 weeks2
Costed roadmap
Every gap gets a specific fix, an estimated cost, and a timeline. You see exactly what must be spent now and what can safely wait.
1-2 weeks3
Execution
Engineering, documentation, qualification, validation and training, designed, specified and supervised through commissioning and inspection.
6-18 months4
Sustain
Weekly or monthly visits. Live documentation updates. Retraining with effectiveness checks. Audit support whenever you need it.
Up to 5 yearsWho we serve
Every dosage form has its own inspection risk.
A sterile facility fails for different reasons than an oral solid dosage unit. We bring the right checklist to the right plant.
- Oral Solid Dosage
- Liquid Orals and Syrups
- Sterile and Injectables
- API and Bulk Drug
- Cosmetics
- Nutraceuticals and Ayurvedic
- Ophthalmic and Topical
- Veterinary Products
Who we work with
Case study
A 40-year-old plant, brought to Schedule M in 11 months.
An oral solid dosage facility in Vatva GIDC with a valid licence, an HVAC system designed under the 2001 standard, no formal Pharmaceutical Quality System, and two outstanding inspection observations.
The situation
74 gaps found. 11 of them critical.
Our gap assessment ran four weeks and covered facility, utilities, equipment, documentation and personnel. The critical items clustered around air handling, differential pressure control, and change control documentation.
11Critical
29Major
34Minor
The outcome
Licence renewed. Both observations closed.
- HVAC redesigned and requalified to the revised standard
- Full PQS built: SOPs, BMRs, change control, deviation handling
- All 74 gaps closed and verified against the original report
- Delivered under the original vendor quote by separating scope
11 MONTHS · GAP ASSESSMENT · HVAC REDESIGN · QMS · QUALIFICATION · TRAINING
In their words
What clients say
They walked the plant for four days before they quoted us anything. The gap report told us two of the three things our previous consultant flagged as urgent could wait eighteen months. That alone paid for the engagement.
Sample: awaiting client approval
What mattered on inspection day was that their engineer was standing in the room and could answer the differential pressure question himself. Most consultants are on a phone in another city by then.
Sample: awaiting client approval
The monthly visits are the reason our documentation is still current two years later. We had SOPs before. What we did not have was anyone making sure they matched what the operators actually do.
Sample: awaiting client approval
Insights
Latest from the floor
Regulatory changes explained by people who have to implement them on Monday morning.
Overview
Unlocking Success with Pharmateq GMP Solution
From facility design and equipment qualification to process validation and documentation management — how one system covers the whole production operation.
Manufacturing
Streamlining Pharmaceutical Manufacturing
Where the time actually goes on a production floor, and how tighter quality control and documentation cut cost, recalls and review cycles.
Guide
Exploring Pharmateq GMP Solution
A walkthrough of what compliance with FDA and EMA expectations demands of a plant, and what changes once you have it.
Questions
The five we are asked most
How long does Revised Schedule M compliance take?
A gap assessment takes 2-4 weeks. Full remediation typically runs 6 to 18 months, depending on how much civil, HVAC and utility work your facility needs. Documentation-only gaps can be closed in 3-4 months.
What does a Schedule M upgrade cost?
Industry estimates for a full MSME facility upgrade commonly fall between Rs 10 and Rs 15 crore, but that figure assumes a complete rebuild. Most plants we assess need considerably less once mandatory items are separated from optional ones. We give you a costed breakdown before you commit to anything.
Do you work outside Gujarat?
Yes. We are based in Ahmedabad and work across India, including Baddi, Indore-Pithampur, Hyderabad and Mumbai. For clients outside Gujarat we typically combine monthly on-site visits with continuous remote documentation support.
Will you be present during the actual inspection?
Yes. Presence and support during customer and regulatory audits is part of our standard engagement.
What is the difference between Schedule M and WHO-GMP?
Revised Schedule M is India statutory GMP requirement under the Drugs and Cosmetics Rules, and mandatory for every licensed manufacturer. WHO-GMP certification is a separate, voluntary certification usually required for export markets. The revised Schedule M was aligned with WHO standards, so a compliant plant is well positioned for WHO-GMP, but they are not the same thing and require separate documentation.
Where we are
On your floor, not three cities away.
We are in Jagatpur, Ahmedabad, which puts us inside an hour of Vatva, Naroda, Odhav, Sanand, Changodar and Bavla. That is why weekly site visits are a real offer and not a line in a proposal.
- OfficeE-905, Ganesh Glory 11
Jagatpur, Ahmedabad, Gujarat 382470 - Phone+91 63532 78772
- Emailhello@pharmateqgmp.com
- HoursMonday to Saturday, 9:30 to 18:30 IST
- Vatva GIDC
- Naroda GIDC
- Odhav
- Sanand
- Changodar
- Bavla
- Vadodara
- Ankleshwar
- Baddi
- Indore-Pithampur
- Hyderabad
- Mumbai
Start here
Find out what your plant actually needs.
A 30-minute call, no charge, no obligation. Tell us your dosage form, your licence status and your deadline. We will tell you honestly whether you have a documentation problem, an engineering problem, or both.
- A senior consultant on the call, not a salesperson
- A written summary of what we discussed within 48 hours
- No proposal until you have seen a gap report
Request a free gap assessment
We reply within one working day.