Quality Management System
Speak with Us
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Good Distribution Storage Practice for Pharmaceuticals and Medical Devices
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Pharmacovigilance Site Master File
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Good Pharmacovigilance Practice
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Good Manufacturing Practice
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ISO 13485
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Temperature Validation, Mapping & Monitoring
Quality Management System
Set Up Maintenance & Audits
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Pharmaceutical Import/Export License
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Audits & Compliance
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Pharmacovigilance Site Master File
Our Experience
PEACN.Solutions has own set up and also helped companies obtain a pharmaceutical import and wholesale license. We can assist to set up Quality Management System in Good Distribution Practice (GDP), Good Distribution Practice in Medical Devices (GDPMDS), Pharmacovigilance Site Master File (PSMF), or represent you as your infrastructure for a pharmaceutical trading license, so that you may enjoy the benefits of tariff-free international pharmaceutical business in Asia, eg, import and export from / to Singapore, Vietnam, Philippines, Hong Kong etc.
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We have fully licensed, local Health Authority and EU-client audited Quality Management Systems in Good Distribution Practice and Pharmacovigilance for Drugs and Medical Devices, with Regulatory Pharmacists and Local Responsible Persons for Pharmacovigilance to ensure the compliance of your pharmaceutical licenses under our care.
How we can help
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Consultation on company and pharmaceutical infrastructural set up
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Provision of local warehouse or store address qualified to GDP
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Provision of local Pharmacist as licensed responsible person
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Provision of local Person responsible for Pharmacovigilance (LPV / LPPV)
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Set up and maintenance of QMS for GDP
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Set up and maintenance of Pharmacovigilance Site Master File
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Training of related personnel responsible for the QMS
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Audit preparation and handling audit for GDP, Good Manufacturing Practice (GMP), ISO 13485 etc.
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Corrective and Preventive Action (CAPA) investigation and remediation
