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Lifesciences Compliance Services in Indonesia
Our BPOM Regulatory Consultants in Indonesia provide end-to-end support for product registration, approvals, and ongoing regulatory compliance.
Indonesia
BPOM Approval and Product Licensing Guidance
We provide integrated services in the major life sciences industries. As a leading company, Artixio offers our clients to make use of our comprehensive services which include regulatory, market research & access, product lifecycle, testing, pharmacovigilance and more. Join us for ongoing support, customized strategies and faster product approvals.
Regulatory Authority in Indonesia
In Indonesia, the National Agency for Food and Drugs Control (BPOM) is responsible for the drugs and food supervision. The Ministry of Health, Indonesia, is authorized for the medical device regulation. A product license is required for the marketing of pharmaceuticals as well as medical devices. At times it can be confusing to understand which regulations apply in different situations. For instance, in Indonesia, the medical devices are divided into 4 classes. Ranging from low risk to high risk and the requirements are different for each class.
BPOM Local Authorized Representative (LAR) Services in Indonesia
Our BPOM Local Authorized Representative (LAR) services help international companies meet Indonesia’s regulatory requirements with confidence. We act as your official local entity, managing BPOM registrations, documentation, and regulatory communications. This ensures compliant market entry and uninterrupted product lifecycle management in Indonesia.
Regulatory Submission and Documentation Support Services In Indonesia
Our team has hands-on experience supporting regulatory requirements in Indonesia. With deep knowledge of local processes and a practical approach, we help clients navigate submissions, testing, approvals, and ongoing compliance with confidence. Whether it’s product registration, post-approval changes, or market access, we work closely with you at every stage — including document preparation, quality support, and lifecycle management.
We aim to support life sciences companies in bringing safe, high-quality products to global markets. Our work spans across key sectors including pharmaceuticals, medical devices, cosmetics, nutrition, biologics, and animal health. At Artixio, we focus on practical, reliable solutions that help you meet regulatory expectations and reach customers faster.
Artixio: Leading Your Way
Artixio operates in Indonesia through strong regional presence and affiliate networks. This was possible for us through our decades of experience, excellence, flexible and creative attitude in delivering the client needs.
We believe innovation doesn’t happen without genuine interest. Like our clients, we care deeply about bringing meaningful products to market — whether they help treat serious conditions or simply improve everyday life. While the industry often leans toward business goals, we stay focused on making sure only safe, effective, and quality products reach the public.
What sets us apart is the kind of guidance we offer throughout each regulatory step. From identifying gaps to helping accelerate approvals, we adapt our support based on what each product needs. Our understanding of regional rules and market realities helps prevent delays, rejections, or recalls. Big or small, every project matters to us — and we put everything into getting it right for our clients.
Professional Regulatory Consulting Services in Indonesia
Why Artixio For Regulatory Compliance Support in Indonesia?
FAQs
Which CTD format is used in Indonesia?
What are the steps involved in the registration for a BPOM Certificate in Indonesia?
What products require a BPOM Certificate in Indonesia?
What is Izin Edar?
What is the validity period for marketing authorization for products in Indonesia?
Industries We Serve in the Indonesia
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
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