Good Distribution Storage Practice for Pharmaceuticals and Medical Devices
Complete Quality Management System Solutions
PECAN.Solutions provides expert QMS setup and maintenance across all major pharmaceutical and medical device standards:
Pharmaceutical Quality Standards
Pharmacovigilance Site Master File
Good Pharmacovigilance Practice
Good Manufacturing Practice
Medical Device Standards
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:
Key points
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:
We have fully licensed, local Health Authority and EU-client audited Quality Management Systems in:
Key points
Other key Asian markets
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-ready QMS without building from zero
You should not invent a quality system the week before an inspection. We deploy licensed pharmaceutical infrastructure already audited by local Health Authorities and EU clients—with pharmacists and Local Persons for Pharmacovigilance ready to oversee GDP, GMP, GDPMDS, PV, and ISO 13485 expectations for medicines and devices.
That means shorter setup, lower capital burn, and a compliance posture you can defend in for-cause and routine audits alike.
Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership.
Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations.
We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework.
Where pathways differ by product class, we sequence filings to protect the critical path and avoid avoidable deficiency letters.
Engagements can scale from a single dossier workstream to a multi-country virtual regulatory function.
PECAN.Solutions scopes each workstream with milestones, document owners, and authority touchpoints so registration, license holding, and commercial access stay on one plan.
What “ready” looks like
Infrastructure on day one
Audit-qualified QMS and PV SMF frameworks that can absorb sudden inspections without a scramble.
People who can sign
Licensed pharmacists and LPV/LPPV roles that Agencies recognize.
Standards breadth
Experience spanning GDP/GMP, medical-device ISO 13485, and pharmacovigilance operations.
Trading setup support
Help establishing entities for import, export, and re-export of pharmaceuticals under controlled QMS.
Engagement modes
Audit preparation and hosting for GDP, GMP, and ISO 13485
CAPA investigation and remediation
Ongoing compliance monitoring
Rapid QMS / PV SMF standup for for-cause pressure
Engagement notes
- Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership
- Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations
- We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework