Product & Process Validation

Comprehensive validation and qualification of sterile and non-sterile processes, with full regulatory alignment and dedicated project management

A dedicated team offering a wide range of services

Thanks to a dedicated team of project managers, who are all biologists, biotechnologists and chemists with considerable experience in the field, we can offer a wide range of services that include the development and validation of sterile and non-sterile processes, up to the qualification of pharmaceutical and cosmetic finished products.

 

We perform validations for both newly developed and existing processes, adapting to any improvements or modifications.

Our methodical approach to process validation aligns with international regulatory compliance, with each validation tailored to the specific demands, significance, and complexity of the process and equipment.

 

 

Consultancy & Documentation

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Filter Validation and Ancillary Tests

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Primary Packaging Qualification

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In-Process Material Qualification

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MascoLab

Our Validation Laboratory

At the heart of our validation services is MascoLab, DOC’s in-house laboratory designed for high-quality, GMP-oriented testing.
Here, our skilled laboratory technicians perform all analytical and validation activities under strict quality standards, ensuring precision, compliance, and fast response times.


MascoLab is fully integrated into our project workflows, allowing seamless coordination with our project managers and tailored support for every client need.

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MascoLab

From Planning to Audit: We’re by Your Side

Project setup & study design
We coordinate the operational aspects and define the validation approach in line with regulatory requirements — ensuring every study starts with a clear, structured plan.


Documentation development
We prepare protocols and supporting documents tailored to each project.


Execution and monitoring
We supervise all phases, monitor timelines, and provide regular progress updates to ensure clarity and control.


Data analysis & troubleshooting
We review laboratory data, identify trends, support deviation management, and resolve out-of-specification results.


Audit support
Upon request, we provide assistance during inspections and regulatory audits.

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Organization