Integrated regulatory, clinical, and commercial capabilities across Asia-Pacific.
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 TeamGetting 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.
