10 Years of Proven Expertise · ยาเสพติดทางการแพทย์

Medical Narcotics —
Thailand's Most
Demanding Market

ยาเสพติดทางการแพทย์ — ตลาดที่เราเชี่ยวชาญมากกว่า 10 ปี

For over a decade, Biz Success has operated directly in Thailand's medical narcotic drug market — with real registrations, real government tender success, and a real supply chain that meets the strictest compliance standards.

Our Track Record / ประวัติความสำเร็จ

A Decade of Direct Experience
with Thailand's Narcotic Drug System

Biz Success has been operating in Thailand's medical narcotic market for over 10 years. This is not an area where experience can be shortcut — and ours has been earned through real engagement with Thailand's FDA, real registration files, real government tenders, and real supply chain management under strict controlled substance protocols.

Our decade of operation means we have seen regulatory changes, adapted to updated Thai FDA requirements, and maintained continuous compliance through evolving standards. We know this market from the inside.

For international manufacturers who want a partner that can genuinely navigate the complexity of Thailand's narcotic drug system — we are that partner. Not in theory, but in practice, with a decade of proof behind us.

เราดำเนินธุรกิจในตลาดยาเสพติดทางการแพทย์ของไทยมากกว่า 10 ปี มีประสบการณ์ตรงกับ อย. มีทะเบียนที่ผ่านการอนุมัติ มีประวัติการประมูลที่ประสบความสำเร็จ และมีระบบนำเข้าที่ถูกต้องตามมาตรฐาน GSP/GDP

Journey / เส้นทาง 10 ปี

Year 1–3

Foundation & First Registrations

Built initial relationships with Thai FDA reviewers. Completed first narcotic drug registrations and established compliant import protocols under GSP/GDP standards. Learned the system from the inside.

Year 4–6

E-Bidding Success & Market Presence

Successfully entered Thailand's government procurement system — participating in narcotic drug tenders and building a consistent track record of e-bidding results. Product supply chains fully operational.

Year 7–9

Regulatory Expertise Deepens

Adapted to evolving Thai FDA requirements and expanded the product portfolio under management. Strengthened the pharmacist-led RA team and refined dossier preparation processes for controlled substances.

Year 10+

Established International Partner

A proven, trusted partner for international narcotic drug manufacturers — with active registrations, ongoing government tenders, and full supply-chain compliance operating continuously in the Thai market.

Our Capabilities / ความเชี่ยวชาญของเรา

Six Capabilities That Navigate
Thailand's Most Complex Market

Schedule II Narcotic Registration

การขึ้นทะเบียนยาเสพติดประเภท 2

Full management of Thai FDA narcotic drug registration — pre-submission dossier review, e-submission, reviewer liaison, deficiency responses, and controlled substance-specific documentation requirements.

Controlled Substance Documentation

เอกสารเฉพาะผลิตภัณฑ์ควบคุมสูง

Preparation of ACTD, PIC/S, ICH dossiers with the additional controlled-substance documentation layers required by Thai FDA — IPCS reports, stability data, and chain-of-custody records.

GSP/GDP Compliant Importation

การนำเข้าตามมาตรฐาน GSP/GDP

End-to-end narcotic drug importation under GSP/GDP — full traceability, controlled temperature chain, narcotic permit documentation, and customs clearance management for every shipment.

Government E-Bidding (อย. Tender)

การประมูลยาเสพติดภาครัฐ

Proven experience in Thailand's narcotic drug government procurement — qualification documentation, pricing strategy, bid submission, and award management through the Thai FDA's e-bidding framework.

Pharmacist-Led RA Team

ทีมเภสัชกรด้านการขึ้นทะเบียน

Our RA team is led by licensed pharmacists with direct narcotic drug compliance experience — ensuring submissions are accurate and aligned with Thai FDA reviewer expectations from the first filing.

Post-Market Regulatory Continuity

การดูแลหลังขึ้นทะเบียนอย่างต่อเนื่อง

Pharmacovigilance reporting, license renewals, and regulatory updates — maintaining continuous compliance and keeping every narcotic drug registration active, valid, and audit-ready at all times.

Compliance Framework / กรอบการปฏิบัติตามกฎระเบียบ

Operating to the Highest
Controlled Substance Standards

มาตรฐานสูงสุดสำหรับการควบคุมยาเสพติดทางการแพทย์

Thai Narcotics Act (พ.ร.บ. ยาเสพติด)

Full operational compliance with Thailand's Narcotics Act — import permits, stock control, destruction protocols, and all reporting obligations to Thai FDA and relevant authorities.

GSP (Good Storage Practice)

All narcotic drug inventory stored under GSP-compliant conditions — controlled access, temperature monitoring, batch segregation, and complete traceability at every storage stage.

GDP (Good Distribution Practice)

Distribution managed under GDP — validated transport conditions, tamper-evident packaging, chain-of-custody documentation, and delivery protocols fully meeting Thai FDA controlled substance standards.

INCB International Alignment

Operations aligned with International Narcotic Control Board standards — ensuring partners' supply chains meet both domestic Thai requirements and international treaty obligations simultaneously.

Medical Narcotics —Thailand's MostDemanding Market

A Decade of Direct Experiencewith Thailand's Narcotic Drug System