Expert Setup & Compliance

QMS Standards We Support

Quality Management System Services

Our Experience

How We Can Help

Why Choose PECAN.Solutions for Quality Management Systems

Our Case Studies

Ready to Establish Your QMS Compliance?

Quality Management System Asia

Set Up Maintenance & Audits

Complete Quality Management System Solutions

Proven QMS Infrastructure Across Asia

Complete QMS Solutions for Your Business

Your Competitive Advantage in QMS Compliance

Proven QMS Success

Let's Build Your Quality Management System

Singapore Malaysia Philippines Vietnam Thailand Hong Kong Taiwan Indonesia Services Commercial Access Regulatory Consultancy License Holding Quality Management System RLD and Bioequivalence Temperature Validation Contact Us Get In Touch 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

• Pharmaceutical Import/Export License

• Audits & Compliance

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

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

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.

• 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

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.

Singapore

Malaysia

Indonesia

Philippines

Vietnam

Thailand

Macao

Cambodia

Laos

Hong Kong

Taiwan

--> Quality Management System Asia | GDP, GMP & Pharmacovigilance QMS | PECAN.Solutions top of page Home
Markets Singapore
Taiwan
Services Commercial Access
Regulatory Consultancy
License Holding
Quality Management System
RLD and Bioequivalence
Temperature Validation

Ready to Enter Asian Markets?

PECAN.Solutions is your trusted partner for navigating the complex regulatory landscape of Asian pharmaceutical markets. With our network of local experts and proven track record since 2007, we can help you bring your products to market efficiently and compliantly.