Regulatory approvals require scientific expertise. Commercial success requires business acumen. In Asia-Pacific, you need both — in one partner. JNPMEDI APAC brings clinical science, regulatory depth, and a genuine understanding of your commercial goals to every market you enter. This is not optional. It is the only way to build a durable APAC presence.
Companies entering Asia-Pacific face structural risks that most regulatory agencies aren't built to solve. JNPMEDI APAC was specifically designed around these three.
In most APAC markets, registrations must be held by a locally registered entity. That entity should deeply understand your product, your science, and your commercial goals — not just hold a license as a formality. The right partner aligns their success with yours.
Singapore's HSA, Malaysia's NPRA, Indonesia's BPOM, India's CDSCO, Vietnam's DAV, Thailand's TFDA — each with distinct requirements, timelines, and submission pathways. Coordinating across 8 markets without one accountable platform is operationally untenable.
Most APAC regulatory consultancies do registration. Some do CRO. Almost none do MAH, registration, CRO, and commercial access under one roof — forcing companies to manage three separate vendor relationships across every market they enter.
JNPMEDI APAC is the only APAC platform that combines independent MAH and license holding, full CRO capabilities, regulatory affairs consulting, and commercial market access — structured so each service remains independent of the others.
Talk to Our APAC TeamCountry-specific pathways, dossier preparation, authority communication across 8 direct markets.
We hold your registrations independently — not your distributor. Full separation between commercial and regulatory.
Phase I–IV execution, medical writing, CDM, safety monitoring via JNPMEDI Korea's full CRO platform.
Post-registration commercial strategy, distribution, reimbursement, and lifecycle management.
Six primary capabilities, each available independently or as a coordinated platform — covering both medical devices and pharmaceuticals.
HSA registration, APAC device market access, and independent license holding across Singapore and partner markets.
Learn More →Drug registration, regulatory strategy, NDA/ACTD, and MAH support for pharma and biotech entering Singapore and APAC.
Learn More →We hold your product licenses independently of your distributors — protecting IP and commercial flexibility across APAC markets.
Learn More →Phase I–IV trials, medical writing, CDM, and clinical project management via JNPMEDI's full CRO platform.
Learn More →Classification strategy, dossier preparation, gap analysis, post-market surveillance, and lifecycle regulatory management.
Learn More →eTMF, CDMS, eCOA, Safety, and CDISC-compliant digital clinical infrastructure for APAC trial operations.
Learn More →In most APAC markets, product registrations must be held by a locally registered entity. Choose one that genuinely understands your product, your market ambitions, and your commercial partners — and shares the same vision for success.
JNPMEDI APAC serves as your independent Registrant, Marketing Authorization Holder (MAH), or equivalent local representative — a partner who genuinely understands your product's science, your commercial ambitions, and the APAC markets you are entering together.
We work closely with you and your distribution partners to align on a shared vision of market success. Whether you need an MAH, a License Holder, or a fully integrated commercialization partner — we bring the same commitment: your APAC success is ours.
Get License Holding ProposalAdd or replace commercial partners at any time without triggering re-registration or compliance delays.
One stable point of contact with local regulatory authorities across your entire APAC product portfolio.
Real-time tracking of regulatory changes that affect your product's compliance status in each market.
Annual filings, license amendments, variation submissions, and transfer management — handled on your behalf.
Bringing a medical device to market in Asia-Pacific requires more than a regulatory submission. It requires a local partner who holds your licenses independently, communicates with authorities on your behalf, and manages ongoing compliance — without forcing you into an exclusive commercial relationship.
JNPMEDI APAC serves as your HSA-registered Registrant in Singapore and coordinates device registration across APAC through direct operations and qualified local partners.
Pharmaceutical registration in Asia-Pacific demands precise regulatory strategy, country-specific dossier expertise, and in some markets, a local Marketing Authorization Holder (MAH) or equivalent local representative.
JNPMEDI APAC provides drug regulatory strategy and MAH-related support across Singapore and key APAC markets — grounded in JNPMEDI Korea's clinical platform and covering development-stage strategy through post-approval lifecycle management.
JNPMEDI APAC is connected to JNPMEDI Korea's full Contract Research Organization (CRO) platform — one of Korea's most active clinical service providers, with ongoing contracts across major Korean and global pharmaceutical companies.
This means JNPMEDI APAC can support more than registration. We help design and execute clinical programs in APAC — from Phase I to Phase IV — with the scientific leadership and operational infrastructure to move efficiently through APAC development and approval pathways.
Maven Clinical Cloud is JNPMEDI's proprietary digital clinical operations platform — designed for the complexity of multi-site, multi-country APAC clinical trial execution. It provides integrated eTMF, CDMS, eCOA, safety monitoring, and CDISC-compliant data standards in a single unified environment.
Effective regulatory strategy determines how your product is classified, which pathway is most efficient, where it can enter first, and how a regional rollout should be sequenced. JNPMEDI APAC provides RA consulting for both medical devices and pharmaceuticals — from early-stage classification through post-approval lifecycle management.
Talk to Our Regulatory TeamJNPMEDI APAC operates directly in eight strategic markets. For additional APAC coverage, we coordinate through qualified local partners — with clear delivery accountability throughout.
| Market | Regulatory Body | Direct Capabilities |
|---|---|---|
| Singapore ★ | HSA | Regional HQ · Device & Drug Registration · Registrant / License Holder · GDPMDS · Full APAC hub |
| South Korea Group HQ | MFDS | JNPMEDI Group HQ · CRO Platform · Phase I–IV · Maven Clinical Cloud · RA Consulting |
| United States | FDA | FDA regulatory strategy · De Novo expertise · US market access and commercial support |
| Malaysia | NPRA | Medical device & drug registration · Authorized Representative services |
| Indonesia | BPOM | Device and drug registration · Direct compliance operations |
| India | CDSCO | Drug & device registration · Direct RA consulting and regulatory execution |
| Vietnam | DAV | Device and drug registration · Direct operations and compliance support |
| Thailand | TFDA | Device and drug registration · Direct RA consulting |
Beyond eight direct markets, JNPMEDI APAC coordinates regulatory, clinical, and commercial services across additional APAC and global markets through qualified local partners — including Australia, Japan, Hong Kong, Taiwan, the Philippines, New Zealand, and select EU markets. One coordinated platform. Clear delivery accountability.
We connect regulatory affairs, clinical development, CRO execution, digital clinical infrastructure, and commercialization — under one coordinated platform. Most APAC regulatory agencies offer only one or two of these capabilities.
JNPMEDI APAC covers medical devices and drugs under one relationship, one strategic overview, one coordinated APAC platform — across both product categories and all lifecycle stages.
We hold zero distributor equity and no commercial agreements. Our regulatory and license holding services are structurally independent — protecting your commercial freedom in every market we operate, for the lifetime of your product.
250+ active studies, 1,500+ sites online, 12.4M eTMF documents managed through Maven Clinical Cloud. Our regulatory and clinical team carries direct experience across FDA, APAC authority interactions, and global pharmaceutical CRO operations.
We review your product, target markets, existing registrations, and commercial setup to identify the optimal APAC pathway — no charge for initial consultation.
Country-specific classification, pathway selection, timeline, and submission sequencing — for each target market in your APAC expansion plan.
We are established as your independent Registrant or MAH before submission — ensuring structural separation from any commercial relationships from day one.
Dossier preparation, authority submission, deficiency management, and approval follow-through — coordinated across all target markets simultaneously where applicable.
License maintenance, variation management, PMS, and commercial market access support — for the full lifecycle of your product in each APAC market.
Seeking HSA registration, APAC market access, and independent license holding — without distributor dependency.
Needing drug registration, MAH support, and regulatory strategy for Singapore and APAC markets.
Registering Software as a Medical Device, navigating APAC digital health regulations, and leveraging Maven for clinical data infrastructure.
Expanding from Korea into Singapore, Southeast Asia, and the broader APAC region — leveraging JNPMEDI's Korea-to-APAC network.
Needing MFDS strategy, Korean regulatory execution, and connection to JNPMEDI's Korea-based CRO and clinical platform.
Wanting a single partner for both APAC clinical trial execution and local regulatory strategy — without managing two separate vendor relationships.
Getting a device registered is only half the work. Moving registered product through APAC channels requires a local distribution infrastructure that understands both regulatory obligations and commercial realities.
JNPMEDI APAC provides direct distribution support for registered medical devices across Singapore and key APAC markets — as an independent distributor, fully separated from your license holding relationship.
Singapore is the gateway to Southeast Asian consumers for K-Beauty and cosmetic brands. Entering the Singapore and APAC market requires product registration, import licensing, compliant labelling, and a distribution strategy suited to local retail and e-commerce channels.
JNPMEDI APAC provides end-to-end K-Beauty and cosmetic distribution support — from HSA cosmetic product notification through to retail shelf and online marketplace placement across Singapore and Southeast Asia.
We respond within one business day with a clear assessment of your regulatory pathway, timeline, and the right structure for independent license holding in your target markets.
Tell us about your product and target markets. Our regulatory and clinical team will respond within one business day with a clear assessment of your pathway, timeline, and next steps.
