Plant Design & Turnkey Projects
GMP facility layouts, material and personnel flow, HVAC and cleanroom design, purified water, WFI and clean steam engineering, URS and detailed engineering packages. Concept to completion.
- LAYOUT
- HVAC
- WFI
- URS
Services
GMP Consulting Services
Pharmateq covers seven disciplines: plant design and turnkey projects, GMP compliance and upgradation, audits and inspection readiness, documentation and QMS, qualification and validation, training, and regulatory licensing.
Last updated: 14 August 2026
What we do
Seven disciplines. One team. No coordination gaps.
Most plants need four or five of these at once. Running them through six separate vendors is where schedules slip and documentation contradicts itself.
GMP Compliance & Upgradation
Revised Schedule M, WHO-GMP, EU-GMP and PIC/S, US FDA inspection readiness, with a hard focus on the lowest justifiable cost. We tell you what you must spend on, and what you do not.
- SCHEDULE M
- WHO-GMP
- EU-GMP
- 5-YEAR RETAINER
Audits & Inspection Readiness
Full gap assessments against every clause. Mock audits where our team inspects your facility as a regulator would. Supplier qualification audits. CAPA management.
- GAP ASSESSMENT
- MOCK AUDIT
- CAPA
Documentation & QMS
Pharmaceutical Quality System, SOPs, batch manufacturing records, Site Master File, Validation Master Plan, Quality Risk Management files, and CTD/ACTD dossiers.
- PQS
- SOP
- BMR
- SMF
- QRM
Qualification & Validation
DQ, IQ, OQ, PQ for equipment, machines and facilities. Process and cleaning validation. Hold time studies. Temperature mapping. Computerized System Validation. Data integrity and ALCOA+ controls.
- DQ/IQ/OQ/PQ
- CSV
- ALCOA+
Training & Capability Building
cGMP, GDP, GLP, Data Integrity, Train the Trainer, 5S and personal hygiene. Every programme ends with a documented effectiveness evaluation.
- cGMP
- DATA INTEGRITY
- 5S
Regulatory & Licensing
All FDCA and CDSCO work: plant approval, manufacturing licence, GMP certificate, GLP certificate, product permissions and endorsements, and product development support.
- FDCA
- CDSCO
- LICENSING
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 yearsQuestions
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.
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.