● Product Registration (Medical Device, Household Device (PKRT), Food, Health Supplement, Traditional Medicine, Drug, Quasi Drug, and Cosmetic)

We provide service in doing dossier review, dossier preparation, dossier submission, advocating, and following up to related government until the license is issued.

● Regulatory Intelligence

To support business coming to and growth in Indonesia, we provide the regulatory intelligence service. This service includes local partner due diligence, product pre-screening, daily regulatory advice, etc.

● Halal Certification

Due to Halal certification which is started to be mandatory in 2019, we are willing to support our clients in registering halal to be able to reach most moslem population in Indonesia. This service also covers the facility preparation for halal audit and halal dossier submission to government agency.

● Company Certification

We support clients in obtaining the facility related-certificates, such as GMP certificates and production license for manufacturing, and operational license for healthcare products’ importer.  Our scope of service is starting from the layout drawing, SOP preparations, until the license issuance

● Technical Translation

With the experience of our members in translating technical documents, such as Medical Device’s manual, Drug’s brochure, scientific journal, clinical data, etc., we expect to be able to support client in translating the required documents, from English to Bahasa Indonesia and vice versa.