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Who We Are

Built on values of integrity and clarity, our communication and documentation processes.
Aspiring to become the trusted name synonymous with excellence, dependability, and forward-thinking solutions in pharmaceutical services.
QualiZen – Guiding Pharma with Quality, Clarity & Confidence

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Everything you need
End-to-End Regulatory Support

From dossier preparation to post-approval maintenance

Global Compliance Expertise

Deep knowledge of EMA, USFDA, WHO, DCGI, ANVISA, MHRA, and GCC regulations

Audit Excellence

We deliver high-quality audit reports, structured SOP-driven inspections

Specialized Technical Services

From IVRT/IVPT and nitrosamine impurity testing to in-vitro bioequivalence studies

Integrated Project Management

centralized coordination, timeline monitoring, and resource optimization,

Transparent Approach

Built on values of integrity and clarity, our communication and documentation processes

Quality
Quality

Ensuring GxP Compliance Through Robust Systems, Audits And Continuous Improvement.

Deep Insight Into Regulatory Landscapes, Client Expectations And Scientific Principles That Drive Compliance.

Delivering Confidence Through Validated Processes, Inspection Readiness And Unwavering Regulatory Alignment.

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Leadership
Leadership

Empowering Clients With Expert Guidance And Strategic Foresight To Navigate Complex Compliance Challenges.

Upholding Ethical Standards And Transparency In Every Engagement – Doing The Right Thing, Always.

Reflecting Our Energetic And Enthusiastic Approach To Solving Compliance Challenges And Driving Clients Success.

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Excellence
Excellence

Striving For The Highest Standards In Service Delivery, Documentation And Regulatory Outcomes.

Providing Clear Direction Through The Complexities Of Gxp Compliance, Regulatory Strategy And Operational Execution.

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We Serve Globally

QualiZen proudly delivers services across international markets, adhering to regional regulations including USFDA, EMA, WHO, DCGI, ANVISA, MHRA, GCC, and others. Clients trust our insights, experience, and commitment to quality.

Start with the customer – find out what they want and give it to them.

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