Full Services Directory
Categorized service offerings covering plant setup, compliance audits, validation execution, regulatory dossiers, and lab upgradation.
1. Project & Facility Engineering
Project Management
Complete support for erecting manufacturing facilities from conceptual design to project completion.
Learn More →Plant Layout Designing
Facility layout design in full compliance with international cGMP norms and project execution support.
Learn More →Facility / Lab Upgradation
Modernizing existing suites, HVAC integration, laboratory setup & Good Laboratory Practices (GLP).
Learn More →2. Quality, Audit & Compliance
Audit Preparation Support
Facility readiness for WHO-GMP & national regulatory audits and compliance remediation.
Learn More →Facility GAP Analysis
In-depth assessment of facility engineering, HVAC, water systems, and QMS against regulatory guidelines.
Learn More →Vendor Audit Services
Audits for formulation, raw material (RM), packing material (PM), public testing laboratory, and laundry vendors.
Learn More →3. Qualification & Validation Execution
Facility & Equipment Qualification
Qualification protocols and execution for HVAC systems, Purified Water, Clean Utilities, and Equipment.
Learn More →Process & Cleaning Validation
Process validation protocols, cleaning validation matrices, swab sampling plans, and residue limit rationale.
Learn More →Computer System Validation (CSV)
CSV execution as per GAMP 5 and 21 CFR Part 11 for computerized lab instruments and automated systems.
Learn More →4. Regulatory Documentation & Technical Support
Dossier Preparation & FDA Approvals
Regulatory dossier compilation, FDA/DCGI online submission, documentation coordination & approval tracking.
Learn More →Document Preparation (SMF, SOP, VMP)
Site Master File (SMF), Quality Manual, Validation Master Plan (VMP), URS, DQ/IQ/OQ/PQ, PVP/PVR, and SOPs.
Learn More →Technical Troubleshooting
Troubleshooting sterility issues, deviations, OOS, media fill failures, stability studies, and artwork review.
Learn More →