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Life Sciences Product Registration Services in Indonesia
End-to-end registration support in Indonesia with BPOM, Ministry of Health, and Dirjen PKH for market access across regulated sectors.
Services We Offer
Regulatory Approval for Life Sciences Products in Indonesia
Indonesia’s regulatory environment for product registration is strict, and understanding its processes is crucial for a smooth market entry. Artixio specializes in helping businesses navigate the registration process for all life sciences industries, including Pharmaceuticals, MedTech, Cosmetics, Nutrition, Biologics, and Veterinary products. Our approach ensures that products comply with local regulations and achieve successful market approval in Indonesia.
Step-by-Step Product Registration Process in Indonesia
We manage the entire lifecycle of product registrations in Indonesia through BPOM, MoH, and Dirjen PKH with expert guidance on compliance and approvals:
- Product Classification
- Regulatory Body(BPOM) Engagement
- Dossier Preparation
- Submit to BPOM
- Approval & Licensing
- Post-Market Compliance
Why Artixio for Life Sciences Product Registration in Indonesia?
- Local regulatory expertise to guide you through BPOM requirements
- Streamlined document preparation and submission process
- Local presence with a network of experienced professionals
- Proven success in securing approvals for a wide range of products
FAQs
Which authority handles product registration in Indonesia?
The National Agency of Drug and Food Control (BPOM) is responsible for product registration across life sciences sectors.
Is a local representative required for product registration?
Yes, a local license holder or Indonesian-registered entity is mandatory to initiate and complete the registration process.
Are documents required to be translated into Bahasa Indonesia?
Yes, most technical documents, including labels and packaging inserts, must be submitted in Bahasa Indonesia.
Is importation allowed during the registration process?
No, importation is only permitted after receiving the product registration certificate from BPOM.
Do registered products need to be renewed in Indonesia?
Yes, registration certificates typically have a validity period and must be renewed before expiry to continue marketing the product.
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Industries We Serve in the Indonesia
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
Expert Regulatory Services To Streamline Compliance
Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review
Regulatory Affairs Across Multiple Countries
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
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