LB Quality Process
LB QUALITY PROCESS

Beyond compliance.
Intelligence for decisions.

Regulatory Affairs · Quality · Processes

Clarity to move forward.

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Institutional relationships

Selected clients

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Regulation provides direction.

We interpret requirements, assess impacts and develop regulatory pathways.

Quality sustains.

We strengthen systems and controls to maintain a state of control.

Processes make it possible.

We connect decisions to engineering, infrastructure and execution.

From strategy to execution.
Our approach

Requirements are the starting point.
Decisions need context.

In regulated industries, compliance is essential. Yet compliance alone does not guarantee sound decisions, robust processes or sustainable operations.

LB Quality Process combines regulatory intelligence, quality management and process knowledge to support sound technical decisions—from solid-dose medicines and sterile products to projects in other regulated sectors.

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Our services

Technical expertise
applied to operations.

Assessment, strategy and implementation across complementary areas of expertise.

Illustrative editorial image: Quality Management System (QMS)
QUALITY

Quality Management System (QMS)

Assessment, development and improvement of quality systems, with an emphasis on risk, evidence and control.

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Illustrative editorial image: Engineering and Industrial Processes
PROCESSES

Engineering and Industrial Processes

Projects, facilities, flows and manufacturing processes designed around regulatory requirements and real operating conditions.

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Illustrative editorial image: Regulatory Intelligence and Affairs
REGULATORY AFFAIRS

Regulatory Intelligence and Affairs

Interpretation of requirements, regulatory authorization of products and companies, and support for interactions with health authorities.

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Sectors we serve

Expertise across
regulated environments.

Pharmaceutical manufacturing, compounding, medical devices, cosmetics, food supplements, medicinal cannabis, distribution, fractionation and laboratories.

Medicines

Pharmaceutical manufacturing

Medicines

Compounding pharmacies

Regulated products

Medical devices

Regulated products

Cosmetics

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REGULATIONQUALITYPROCESSES
People and experience

Technical knowledge becomes meaningful
in practice.

We work closely with organizations, interpreting requirements, assessing risk and implementing consistent processes.

Meet Luciana Barbosa and Luciene Boroski.

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LB Insights

Technical information
to guide decisions.

Official sources, relevant issues and critical analysis of regulation, quality and processes. We distinguish regulatory updates from technical interpretation.

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Luciana Barbosa and Luciene Boroski — LB Quality Process
Next steps

What decision does your project
need to make now?

Tell us about an operation, implementation, improvement, inspection or technical challenge. We start by understanding your needs before proposing a way forward.

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