Our Services

Four practices.
One integrated platform.

From regulatory roadmaps to clinical execution, market entry, and the people who run it all — AlphaMedic is the single accountable partner for your MedTech journey.

Medical Device Regulatory Management
01
Service 01

Medical Device Regulatory Management

Unified regulatory strategy across major global markets — local expertise powered by global standards.

Regulatory Affairs Consulting

  • Global RA Consulting & Strategy Development
  • LM / RP / LRP alignment
  • Documentation Planning
  • Risk Minimization

Device Registration (HK, Taiwan, China)

  • HKMDD (Hong Kong)
  • TFDA (Taiwan)
  • NMPA (China)
  • End-to-end Registration Roadmap
  • Pre-market to Post-market Support

In-Country Representation (HK, Taiwan)

  • Local Responsible Person (LRP) — Hong Kong
  • In-Country Representative — Taiwan
  • Compliance monitoring
  • Regulatory risk management
Clinical Research (CRO)
02
Service 02

Clinical Research (CRO)

Integrated clinical trial ecosystem with proven experience in Hong Kong and across APAC.

Capabilities

  • Experience managing clinical trials in Hong Kong
  • PMCF / IRB / EC support
  • Site Management
  • Real-world evidence generation
Commercialization & Market Access in Asia
03
Service 03

Commercialization & Market Access in Asia

From distributor mapping to hospital procurement — practical pathways into APAC markets.

Capabilities

  • Distributor Landscape Mapping
  • Market-entry Ecosystem
  • APAC product launch experience
  • Hospital procurement pathways
Talent Advisory
04
Service 04

Talent Advisory

Strategic talent advisory and regional networks to build teams that support long-term success.

Capabilities

  • Strategic talent advisory
  • RA / QA / Clinical / BD / Sales recruitment
  • Regional network & leadership hiring
  • Build teams that support long-term success

Let's map your pathway in 30 minutes.