Training
GMP (Good Manufacturing Practices)
Core principles of quality manufacturing, documentation practices, personnel hygiene, equipment handling, and deviation management aligned with global standards
Schedule M & CDSCO Guidelines
Practical training on India's revised Schedule M requirements and CDSCO regulatory expectations, helping teams align manufacturing and quality practices with current domestic regulatory standards
​Quality Risk Management, Validation & Auditing
We provide integrated support across risk management, validation, and audit readiness — helping you build a defensible, inspection-ready quality system from end to end.
GMP Auditing
We perform in-depth GxP facility inspections and gap analyses to ensure total readiness for CDSCO, US FDA, and EMA audits. Our experts verify that your site processes surpass international benchmarks for safety and quality control.
Validation & Full Lifecycle Services
We provide end-to-end validation and qualification for greenfield and brownfield projects, covering CSV, cleaning, process and analytical method validation, enterprise systems (SAP, ERP, QMS, MES), laboratory systems (LIMS, CDS, ELN), SCADA and IT infrastructure, equipment qualification (DQ/IQ/OQ/PQ), cleanroom and HVAC validation, and temperature mapping, all aligned with US FDA, WHO and international standards.
Quality Risk Management
We implement systematic risk-based approaches across the drug lifecycle, utilizing ICH Q9 methodologies to safeguard patients. By aligning with WHO and US FDA expectations, we provide data-driven strategies that mitigate contamination risks and ensure continuous process improvement.
Manpower & Consultant Staffing
Not every project needs a full engagement. We place experienced independent consultants and technical professionals into your regulated operations against a defined scope, so you pay for outcomes, not overhead.
Industries served: pharmaceutical, biotechnology, medical devices, cosmetics, and food and nutraceuticals.
Roles we staff:
- QA, QC and validation specialists
- Computerised system validation (CSV) consultants
- cGMP and supplier auditors
- Regulatory affairs professionals
- Engineering and qualification specialists
- Trainers for GxP and soft skills
How we place them:
- Project-based: a single audit, validation cycle or training rollout, delivered to a fixed scope and timeline
- Embedded and interim roles: a consultant inside your QA/QC team, on-site or remote, to bridge hiring gaps and leave cover
- Fractional QA or validation lead: a senior consultant part-time, without a full-time hire
Hiring Consultants & Freelancers
Not every project needs a full engagement. We staff independent consultants against a defined scope, so you pay for outcomes, not overhead — every engagement scoped, timed and priced before work begins. For dedicated staffing support, see our Manpower & Consultant Staffing service above.
Every engagement starts with a short scoping call to confirm deliverables, timeline and pricing — no obligation, no surprises.
Project-based
A single audit, validation cycle or training rollout, delivered to a fixed scope and timeline.
Fixed fee, agreed before kick-off
Clear, dated deliverables
Ideal for time-boxed remediation
Ongoing advisory
Continued access to a consultant for recurring compliance and quality needs.
Retainer or day-rate options
Scales up or down with workload
Priority access ahead of inspections
Embedded & interim roles
A consultant placed inside your QA/QC team, on-site or remote, for as long as you need coverage.
Bridges hiring gaps and leave cover
Works inside your own SOPs and systems
Structured knowledge transfer on exit