Quality Management System Asia
Expert Setup & Compliance
Set Up Maintenance & Audits
Establish and maintain comprehensive Quality Management Systems across Asia with our licensed pharmacists and audit-qualified infrastructure. We provide complete QMS solutions for GDP, GMP, Pharmacovigilance, and ISO 13485 compliance.
QMS Standards We Support
Complete Quality Management System Solutions
PECAN.Solutions provides expert QMS setup and maintenance across all major pharmaceutical and medical device standards:
Pharmaceutical Quality Standards:
• Good Distribution Storage Practice for Pharmaceuticals and Medical Devices
• Pharmacovigilance Site Master File
• Good Pharmacovigilance Practice
• Good Manufacturing Practice
Medical Device Standards:
• ISO 13485
• Temperature Validation, Mapping & Monitoring
Quality Management System Services
Set Up Maintenance & Audits
• Pharmaceutical Import/Export License
• Audits & Compliance
• Pharmacovigilance Site Master File
Our Experience
Proven QMS Infrastructure Across Asia
Licensed Pharmaceutical Infrastructure
PECAN.Solutions has our own setup and also helped companies obtain pharmaceutical import and wholesale licenses. We can assist to set up Quality Management Systems in:
• Good Distribution Practice (GDP)
• Good Distribution Practice in Medical Devices (GDPMDS)
• Pharmacovigilance Site Master File (PSMF)
• Represent you as your infrastructure for pharmaceutical trading licenses ​
Benefits of Our Infrastructure
Enjoy the benefits of tariff-free international pharmaceutical business in Asia, including import and export from/to:
• Singapore
• Vietnam
• Philippines
• Hong Kong
• Other key Asian markets ​
Audit-Qualified Compliance
We have fully licensed, local Health Authority and EU-client audited Quality Management Systems in:
• Good Distribution Practice for Drugs and Medical Devices
• Pharmacovigilance compliance systems
• Regulatory Pharmacists and Local Responsible Persons for • Pharmacovigilance
• Ensuring full compliance of your pharmaceutical licenses under our care
How We Can Help
Complete QMS Solutions for Your Business
Infrastructure & Personnel
• Consultation on company and pharmaceutical infrastructural setup
• Provision of local warehouse or store address qualified to GDP
• Provision of local Pharmacist as licensed responsible person
• Provision of local Person responsible for Pharmacovigilance (LPV/LPPV)
​
QMS Setup & Maintenance
• Setup and maintenance of QMS for GDP
• Setup and maintenance of Pharmacovigilance Site Master File
• Training of related personnel responsible for the QMS
​
Audit & Compliance Support
• Audit preparation and handling audits for GDP, Good Manufacturing Practice (GMP), ISO 13485
• Corrective and Preventive Action (CAPA) investigation and remediation
• Ongoing compliance monitoring and maintenance
Why Choose PECAN.Solutions for Quality Management Systems
Your Competitive Advantage in QMS Compliance
Licensed Infrastructure
Fully licensed pharmaceutical infrastructure with local Health Authority and EU-client audited Quality Management Systems ready for immediate deployment.
​
Qualified Personnel
Licensed pharmacists and Local Responsible Persons for Pharmacovigilance (LPV/LPPV) ensuring expert oversight of your compliance requirements.
​
Multi-Standard Expertise
Comprehensive experience across GDP, GMP, GDPMDS, Pharmacovigilance, and ISO 13485 standards for pharmaceuticals and medical devices.​
Rapid Deployment
Existing audit-qualified infrastructure eliminates lengthy setup times, enabling immediate compliance support for your operations.
​
Audit Readiness
Proven track record with local Health Authorities and EU client audits, ensuring your QMS meets the highest compliance standards.
​
Cost-Effective Solutions
Avoid the significant investment required to build and maintain your own QMS infrastructure while ensuring full regulatory compliance.
Our Case Studies
Proven QMS Success
• Setting up a Pharmaceutical Company to facilitate trading of Import / Export / re-Export of Pharmaceuticals.
• Set up of QMS and PV SMF to handle sudden for-cause audit
Ready to Establish Your QMS Compliance?
Let's Build Your Quality Management System
Don't let QMS complexity delay your Asian operations. Our expert team, backed by licensed infrastructure and audit-qualified systems, is ready to establish and maintain your Quality Management System across multiple Asian markets and regulatory standards.
Contact us today to discuss how our QMS expertise can ensure your regulatory compliance across Asia.