Bosker Medico - Specialized Pharmacovigilance and Drug Safety Partner

Specialized Pharmacovigilance & Regulatory Partner

Bosker Medico Services is a boutique Pharmacovigilance CRO dedicated to the scientific integrity of drug safety and regulatory data management.

Unlike traditional clinical CROs, we focus exclusively on the high-expertise domains of Drug Safety (PV), Regulatory Medical Writing, and Computer System Validation (CSV). We serve as a technical extension of your safety team, ensuring global GVP compliance and inspection-ready data delivery.

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Our Specialized Safety & Compliance Services

Focused expertise in drug safety monitoring and regulatory documentation.

Specialized Pharmacovigilance (PV) and Drug Safety Services

Pharmacovigilance

End-to-end ICSR processing, aggregate reporting (PBRER/PSUR), and signal management.

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Regulatory and Scientific Medical Writing Services

Medical Writing

Expert authoring of eCTD safety modules, clinical summaries, and regulatory dossiers.

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CSV and 21 CFR Part 11 Computer System Validation

Clinical Research & CSV

GAMP 5 validation, ALCOA+ data integrity auditing, and IT regulatory compliance.

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Site Management Organization (SMO) Clinical Support

SMO Services

Focused site support ensuring high-quality data collection and investigator GCP compliance.

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High-Precision Safety Data Management & Global Regulatory Compliance