Your Path to Compliance and Excellence Starts Here

Ensuring Compliance. Empowering Excellence

A robust Quality Management System (QMS) is at the heart of every successful pharmaceutical organization. It is the foundation for compliance, operational efficiency, and ensuring the highest quality standards in manufacturing, clinical, and regulatory operations. As regulatory requirements evolve, a well-designed and updated QMS is essential to maintain compliance with global standards like WHO, PIC/S, EU GMP, and USFDA.

Qualifyo’s QMS Set-Up, Review & Updation service is designed to enable pharmaceutical companies to meet these challenges head-on while driving operational excellence and regulatory readiness.

Why Does Your Pharmaceutical Organization Need This Service?

Regulatory Compliance
Adhering to global quality standards prevents costly audits, recalls, and operational suspensions.
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Operational Efficiency
Optimized QMS reduces errors, redundancies, and improves processes.
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Adapting to Change
With rapidly changing guidelines, maintaining an up-to-date QMS ensures continued compliance .
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HOW IT WORKS

How Does Qualifyo Provide This Service?

Our approach is customized, comprehensive, and compliant.

01

Assessment and Gap Analysis
We begin with a detailed review of your existing QMS against global regulatory standards to identify gaps and opportunities for improvement.

02

Design and Implementation
Our experts design and implement a tailored QMS framework, considering your organization’s specific operational needs, goals, and compliance requirements.

03

Documentation and SOP Development:
We develop, review, and update key documents, including SOPs, policies, and templates to ensure regulatory alignment.

04

Training and Change Management
We train your teams on the updated QMS processes to foster seamless adoption and sustained compliance.

05

Continuous Improvement
Our support extends to periodic audits and updates to ensure your QMS remains agile and compliant with emerging regulations.

What Does Qualifyo Deliver?

Comprehensive Documentation

Aligned with WHO, PIC/S, EU GMP, USFDA, and other global standards.

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Regulatory Compliant Setup

SOPs, templates, manuals, and more, designed for operational excellence.

Audit Readiness

A QMS that ensures readiness for inspections and audits by regulatory bodies.

Employee Training Materials

Resources to build a quality-centric organizational culture.

Why Choose Qualifyo?​

  • Deep Industry Expertise

    With over 20 years of experience and collaborations with experts worldwide, we bring unparalleled regulatory knowledge.

  • Customized Solutions

    We design QMS frameworks specific to your business needs, ensuring relevance and effectiveness.

  • Regulatory Insight

    Our global team of regulatory experts ensures adherence to current and emerging guidelines.

  • End-to-End Support

    From planning to post-audit corrective actions, we’re with you at every step.

  • Results You Can Trust

    Our clients consistently report reduced operational inefficiencies, improved compliance readiness, and smoother audit experiences.

Benefits of Working with Qualifyo

  • Improved Compliance

    Achieve and maintain alignment with global regulatory standards.
  • Risk Mitigation

    Reduce risks associated with data integrity, quality failures, and non-compliance.
  • Operational Excellence

    Streamlined processes lead to better efficiency and reduced costs.
  • Audit Preparedness

    Be inspection-ready at all times.
  • Scalable Systems

    A future-proof QMS designed to grow with your business.

Take the Next Step Towards a Future-Ready QMS

Ensure your organization operates at peak efficiency and compliance with our QMS Set-Up, Review & Updation services.

Let’s Discuss Your QMS Needs

Schedule a personalized consulting session with our experts.

Ready to Transform Your QMS?

Share your details, and we’ll craft a customized plan and tailored proposal.