Delivering end-to-end GMP and GCP compliance support for pharma, biotech and clinical research innovators.

Services

Our TEAM

Silvana Sekuloski Ph.D. RAC(EU) CQA

Director and Executive Consultant

Quality-focused scientist with over 25 years of experience in the development, implementation, and management of quality systems across the pharmaceutical, and clinical research sectors. Proven ability to ensure compliance with regulatory requirements such as GMP, GCP, TGA, and ISO requirements. Strong track record in quality assurance and quality control, risk management, supplier and internal audits, analytical method validation and team leadership.

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Aneta Sekovanikj B. Chem. Eng.

Executive Consultant

Operations, Quality, and Pharmaceutical Manufacturing leader with 17+ years of experience in production oversight, strategic and tactical direction, and operational excellence. Skilled at
aligning customer needs with company goals while driving process efficiency, resource optimization, and continuous improvement. Proven record of building and leading high-performing teams, managing large-scale operations, and ensuring compliance within EU GMP-
and ISO-regulated environments.

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