Pharmaceutical R&D

Strategy and Execution

Pharmaceutical R&D

Strategy and Execution

From development through manufacturing, grounded in science, data, and regulatory insight.

From development through manufacturing, grounded in science, data, and regulatory insight.

Learn more

Pharmaceutical R&D

Strategy and Execution

Pharmaceutical R&D

Strategy and Execution

From development through manufacturing, grounded in science, data, and regulatory insight.

Learn more

Capabilities

Drug Development Strategy

Liquid and solid dosage form strategy focused on stability, inovation, and lifecycle performance.

Risk Analysis

Identification and mitigation of drug discovery and development risks across all stages.

Extractables & Leachables

Risk-based E&L strategy including material selection, assessment, and regulatory justification.

Statistical Process Control

Statistical monitoring and CPV frameworks for late-stage and commercial manufacturing.

Design of Experiments (DoE)

Efficient experimental design to understand processes and define robust operating ranges.

Technology Transfer

Planning and execution of tech transfer, scale-up, and manufacturing site readiness.

Packaging Analysis

Packaging selection and analysis with focus on stability, compatibility, and regulatory impact.

EU Grants & Project Leadership

Writing, coordination, and execution of EU-funded scientific and innovation projects.

Data Science for Pharma Decisions

Applied statistics and modeling to support formulation, process, and development decisions.

Proven Impact

We focus on delivering measurable outcomes in pharmaceutical development, manufacturing, and innovation. Our work combines scientific leadership, operational transformation, and the creation of defensible intellectual property.
  • Leadership of multiple awarded EU-funded research and innovation projects, including grant writing, coordination, and execution
  • Contribution to multiple patent filings supporting novel drugs, drug forms, manufacturing processes, and data-driven discovery approaches
  • Digital transformation of pharmaceutical R&D and manufacturing workflows, replacing spreadsheet-based processes with automated systems
  • Data-science-driven discovery and development pipelines applied in a way that preserves intellectual property and supports patentability
  • Definition and execution of extractables & leachables strategies, including material selection, risk assessment, and regulatory justification
  • Translation of advanced analytics into regulator-aware execution, supporting development decisions, process control, and lifecycle management

Who We Are

Led by senior pharmaceutical development expertise, we help organizations turn complex data into confident, regulator-aware decisions.




Zyntar is led by Zlatko Smole, PhD, a pharmaceutical scientist with extensive experience across formulation development, manufacturing, process control, and regulatory execution in global pharma and biotech environments.

His work spans the full development lifecycle, from early formulation strategy and risk assessment through late-stage manufacturing, technology transfer, and regulatory interactions.

Depending on project needs, we work with a trusted network of senior scientific experts and academic collaborators in statistics, machine learning, chemistry, and pharmaceutical technologies.

This flexible collaboration model allows us to assemble focused, senior-level expertise while remaining independent, efficient, and closely aligned with each client’s specific challenges.

Let’s Talk

Let’s Talk

Discuss your pharmaceutical development challenges and explore how we can support your project.
Contact us