GMP Audit & Consulting Services

Product Description

We aim to provide the most reliable and preferred service platform to pharmaceutical companies worldwide for R&D cycleregulatory affairs, and GMP compliance with a higher benchmark of quality, integrity, and ethics.

As a Zenovel, we offer various GMP services which can help clients across the globe, ranging from audits to various consulting services. We provide the following comprehensive GMP Quality Compliance services to the pharmaceutical industry.

A.   GMP Audit Services:

 
✔ QMS Audit

✔  Vendor Qualification/Assessment Audit

✔  GAP Audit

✔  Pre-Inspection Audit

✔  Independent Supplier Audit (System & Facil...

Zenovel

  • Country/Region:
    India
  • Founded:
    2020
  • On CPHI since:
    2021
  • Certificates:
    1
  • Employees:
    25 - 49
Company types
Consultancy
Contract Service
Start-up
Primary activities
Biopharmaceutical
Clinical Research
Medical Devices
Other
Regulatory Affairs
Specifications
  • Details
    GMP audit and consulting services for pharmaceutical manufacturers, suppliers, vendors, contract manufacturers, API manufacturers, excipient manufacturers, packaging material suppliers, and quality service providers. Applicable for supplier qualification, vendor audits, QMS review, GAP assessment, CAPA review, regulatory compliance assessment, manufacturing site audits, and inspection readiness support.

  • Selling Points
    Brand Name; Convenience; Experienced Technicians; Guarantee/Warranty; International Approvals/Standards; Product Performance; Quality Service; Reputation; • Independent GMP audits for pharmaceutical manufacturers and suppliers
    • Vendor and supplier qualification audit support
    • QMS audit, GAP audit, and compliance assessment
    • CAPA review, root cause investigation, and audit finding follow-up
    • Deviation, OOS, change control, and documentation review
    • Pre-inspection readiness and mock audit support
    • Remote and onsite audit options based on client requirements
    • Support for API, finished formulation, excipient, packaging material, and contract manufacturing sites
    • GMP training, SOP review, and quality system improvement support
    • Practical, regulatory-aligned, and inspection-focused consulting approach

  • Model
    GMP Audit, Supplier Qualification & Compliance Consulting

Zenovel

  • Country/Region:
    India
  • Founded:
    2020
  • On CPHI since:
    2021
  • Certificates:
    1
  • Employees:
    25 - 49
Company types
Consultancy
Contract Service
Start-up
Primary activities
Biopharmaceutical
Clinical Research
Medical Devices
Other
Regulatory Affairs

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  • Regulatory Support

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Zenovel resources (7)

  • Video Service Overview

    From clinical research to manufacturing and global approvals,  Zenovel partners with pharmaceutical organizations at every stage of the product lifecycle.

    Our expertise across GCP, GMP, and Regulatory Affairs helps teams stay inspection-ready, compliant, and confident—without losing sight of practical, sustainable execution.

    Because compliance isn’t the finish line - It’s the foundation for moving forward.

    Visit us at www.zenovel.com
  • Video Team Introduction

    Meet the minds behind ZENOVEL

    From regulatory strategy to clinical execution, our strength lies in our people—their expertise, their collaboration, and their passion to make a global impact.

    Get a glimpse into the team driving smarter solutions and seamless delivery across the Clinical Research landscape. 
  • Video 2025 Milestones

    2025 at Zenovel, a year defined by execution, compliance, and measurable impact.

    From GMP audits and GCP oversight to complex regulatory engagements, 2025 marked significant milestones across multiple global projects.

    These numbers reflect not just completed projects, but the trust placed in us by sponsors, CROs, and manufacturing partners worldwide.

    As we move forward, our focus remains the same: Regulatory, quality, and GxP excellence; Beyond Compliance.

    Partner with Zenovel for end-to-end GxP and regulatory solutions.

    Visit us at www.zenovel.com
  • Video 2024 Milestone

    2024 was a year of innovation and progress at ZENOVEL. 

    We are proud to have successfully navigated complex regulatory landscapes, conducted groundbreaking First-in-Human studies, strengthened our global footprint, and improved operational efficiency.
  • Video Zenovel at CPhI Milan 2024

    Our team had a fantastic time at CPHI Milan, showcasing our expert solutions and forging new partnerships.
  • Video 2023 GCP Milestones

    Embarking on a transformative journey in 2023, Zenovel achieved significant milestones in clinical research.

    Conducting 210 studies globally, we pushed boundaries with innovative approaches.


    Our commitment to data integrity, electronic compliance and diverse pre-clinical studies sets us apart.


    Grateful to our clients for their trust and collaboration. 
  • Video 2023 GMP Milestones

    Celebrating milestones of ZENOVEL's GMP Services, upholding quality, trust, and compliance! 

    In 2023, Zenovel proudly achieved 332 Audit Days, fostering trust with 50+ clients and delivering 103 top-notch Audit Reports.


    Our global presence spanned across key locations like India, China, the USA, and more, facing regulatory scrutiny from USFDA and EMA.


    From APIs to Finished Formulations, we upheld the highest GMP standards, ensuring excellence in Plant Set-ups, QMS Upgrades, and beyond.


    Join us in a commitment to quality that goes beyond boundaries!