The registration process for new and orphan drugs in Macao typically takes between 30 to 90 days, ensuring a swift market entry.

We require manufacturing authorization, Certificate of Analysis (COA), a sample bottle, and FDA-registered CTD documents to complete the registration process rapidly.

Yes, our process does not require additional clinical trials, allowing for quicker market access.

Once registered, drugs can be distributed across major hospitals in the Guangdong Great Bay Area, Hainan, and Tianjin, covering over 120 million people.

ACA Pharma is fully licensed and compliant with regulatory standards in Macao and New York, holding wholesale drug licenses, retail pharmacy licenses, and DEA licenses.

We establish strong partnerships with US and EU manufacturers, ensuring seamless market entry and distribution of medications.

The Contract Sales Organization (CSO) model involves outsourcing the commercialization processes, including registration and sales, to a specialized organization like ACA Pharma. In this model, ACA Pharma manages all aspects of bringing a drug to market, including regulatory approval, marketing, and distribution, without any additional fees. This model is particularly beneficial for older drugs with short patents and orphan drugs with limited patient populations, as it ensures efficient market entry and maximizes commercial potential.

Our business model requires no additional investment from the manufacturer. We handle all registration, distribution, and logistics aspects.

In Macao, Hong Kong and Singapore, products are covered by local government insurance post-registration. In the Guangdong Great Bay Area, sales proceed on a self-pay basis, and post-national registration, products can be included in national medical insurance.