Taiwan GMP pharmaceutical manufacturing facility
For Importers & Distributors

Importer Regulatory &
Supply Support Platform

From regulatory feasibility to commercial supply — structured support for pharmaceutical importers entering Thailand and ASEAN markets.

Module 01
📋

Regulatory Support

Documentation that gets your product registered

Every inquiry is backed by a complete regulatory documentation package. We prepare and supply the technical documentation your team needs to submit for pharmaceutical registration across Thailand and ASEAN markets.

✓
ACTD Dossier
ASEAN Common Technical Document format, submission-ready
✓
CPP Certificate
Certificate of Pharmaceutical Product from TFDA
✓
BE Data
Bioequivalence study reports for hospital and tender qualification
✓
Stability Studies
Zone IVb long-term stability data for tropical markets
✓
GMP Certificate
PIC/S GMP certification from Taiwan manufacturing facilities
✓
CoA per Batch
Certificate of Analysis for every production batch
Module 02
🌏

Market Entry Support

Navigate registration and tender pathways with confidence

Thailand and ASEAN pharmaceutical markets each have distinct registration requirements and procurement structures. We provide market-specific guidance so importers can plan their registration timeline and commercial strategy accurately.

✓
Thailand FDA Registration
ACTD-based submission pathway and timeline guidance
✓
Import License Coordination
Documentation support for Thailand import license applications
✓
ASEAN Filing Guidance
Registration pathway overview for Malaysia, Singapore, and Cambodia
✓
GPO Tender Readiness
Product qualification support for Thailand government procurement
✓
Hospital Formulary
Documentation aligned with public and private hospital requirements
✓
NLEM Product Matching
Portfolio alignment with Thailand National List of Essential Medicines
Module 03
🏭

Supply Assurance

Reliable supply from registration through long-term commercial operation

Pharmaceutical importers require predictable supply. We coordinate directly with PIC/S GMP-certified Taiwanese manufacturers to ensure batch consistency, transparent lead times, and supply continuity across your product portfolio.

✓
Batch Consistency
Consistent product specifications across every production run
✓
Stable Lead Times
Production scheduling coordinated with your import timeline
✓
Direct Manufacturer Access
No intermediaries — direct visibility into production and QC
✓
Supply Continuity Planning
Quarterly forecasting support for ongoing import programmes
✓
Cold Chain Coordination
Available for temperature-sensitive pharmaceutical products
✓
OEM Manufacturing
Private label and OEM coordination for distributor brands
How It Works

From Inquiry to Commercial Supply

Step 1
Submit Inquiry
Products, documents, volume
Step 2
Regulatory & Capacity Review
Feasibility confirmed
Within 2 business days
Step 3
Quotation
Pricing, MOQ, lead times
Step 4
Contract & Terms
Supply agreement signed
Step 5
Project Initiation
Documents upon signing

Ready to Start an Importer Project Discussion?

Submit your product inquiry and receive a regulatory feasibility response within 2 business days.

Start Importer Inquiry →