GMP Consultants2025-09-11T22:02:28+05:30
GMP Consultants

“Reghelps helped us navigate a complex FDA Onsite audit Smoothly. Their Consulting and training made all the difference.”

Shane C. Peterson

QA Head, Mars Laboratories

GMP Consultants – Regulatory & Compliance Experts

Ensuring Global GMP Compliance from Start to Finish – At Reghelps, our GMP consultants bring deep regulatory expertise and real-world experience to help pharmaceutical, nutraceutical, and medical device manufacturers comply with Good Manufacturing Practice (GMP) standards enforced by regulatory authorities like the US FDA, EU, MHRA, TGA and WHO

Whether you’re planning for a new facility, facing an upcoming audit, or need to respond to an FDA 483 or WHO inspection, our expert team delivers tailored, actionable support for every stage of your compliance journey.

Scope of Our GMP Consulting Services

GMP Gap Analysis & Audit Readiness

    • Internal audits and facility walkthroughs
    • Identification of compliance gaps
    • Audit simulation/mock inspection

SOP Development & Documentation

    • Creation, review, and revision of SOPs
    • Master validation plans, calibration & maintenance procedures
    • Batch manufacturing records & training logs

FDA 483 & Warning Letter Response Support

    • Root cause analysis
    • CAPA design and implementation
    • Timely, professionally written FDA response letters

WHO Prequalification (PQ) Audit Preparation

    • Documentation alignment with WHO TRS
    • Product dossier preparation and submission
    • Site readiness for WHO inspections

GMP Training & Awareness Programs

    • Onsite and virtual GMP training
    • Role-based training modules for QA, QC, production
    • Audit handling and inspector interaction techniques

Facility Layout Review & GMP Plant Design

    • Review of cleanroom layout, HVAC, water systems
    • Cross-contamination control planning
    • Workflow and material/personnel movement validation

service related FAQ’s

Is GMP compliance mandatory for medical device manufacturers?2025-08-06T04:26:10+05:30

Yes, GMP compliance is mandatory for medical device manufacturers who market products in the United States. The FDA enforces GMP through the Quality System Regulation (21 CFR Part 820), which outlines the minimum requirements for design, production, labeling, packaging, and storage of medical devices to ensure safety and effectiveness.

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