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Lifesciences Compliance Services in Indonesia
End-to-end regulatory solutions, operations and assistance services throughout entire regulatory journey of the product.
Indonesia
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.
Comprehensive Services by Artixio, The Global Competitor
Artixio’s regional team of experts can guide you through this effortlessly. As we have subject matter experts and thanks to their countless encounters, we are always one step ahead in meeting the requirements. We serve in a wide range of regulatory activities including but not limited to regulatory affairs, testing, product registration, regulatory operations, market access, post market approval activities, product lifecycle management, quality services, publishing and submission services.
Our vision is to be the trusted life sciences partner and to make sure the safe and efficient delivery of the products for global access. Artixio’s services are widespread in the key life sciences industries which include Pharmaceuticals, Medtech, Cosmetics, Nutrition, Biologics and Animal Health & Welfare.
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.
Discovery of new innovations is never possible without a strong passion for it. We, similar to our clients, are passion driven and work together in bringing new products that treat life threatening conditions or can improve the quality of life of the public. While in this era everything is purely business minded, we focus on safe, effective and quality product entry to the market.
Our global recognition and reputation have built due to strategic guidance we offer in each regulatory phase, customized support, regulatory gap assessment, navigate our clients through complex regulatory compliance systems and expedited product approval. Our experience and skills acquired through dealing with regional regulatory and market requirements have made us efficient in shielding the product from recalls and rejection. We consider all of our projects, small or large, to be equal and our focus is on implementing our services to the fullest and in achieving success for our clients.
Our Services
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Why Collaborate with Artixio?
Proven regulatory success in each stage for 5000+ products.
First- hand expertise across life science compliance services in Indonesia
20+ years of providing calculated, precise regulatory solutions
Successful registration and maintenance of 2000+ licences
Strategic and preventive approach to product rejection/ recalls.
Regional subject matter experts of 15-35 years of experience.
Industries We Serve in the Indonesia
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
Which CTD format is used in Indonesia?
ASEAN Common Technical Dossier (ACTD) is the CTD format used in Indonesia. Unlike eCTD, ACTD has 4 parts. Part I contains table of contents, administrative and prescribing information, Part II should contain quality overall summary and body of data, Part III must have non-clinical overview summary and study reports and lastly Part IV describe clinical overview summary and study reports.
What are the steps involved in the registration for a BPOM Certificate in Indonesia?
Completion of BPOM registration form, preparation of relevant documents according to the type of BPOM Certificate applying for. For cosmetic products submit the documents to NADFC and for food products submit to the BPOM officer. Assessment and evaluation is carried out to ensure product fitness in the Indonesian market. After this, wait for the review of the application. If approved your account will be active.
What products require a BPOM Certificate in Indonesia?
The products include therapeutic products, drug ingredients, narcotics, psychotropics, additive substances, precursor, cosmetics, health supplements and complementary products, processed foods and traditional medicines
What is Izin Edar?
Izin Edar is the distribution permit. Besides from the BPOM certificate, to distribute the product in the market this distribution permit is required.
What is the validity period for marketing authorization for products in Indonesia?
5 years is the marketing authorization validity for products including pharmaceuticals and medical devices in Indonesia. It can be extended via the renewal registration mechanism. The marketing authorization can expire and must be renewed before the date of expiration.
Our Global Reach: Serving Life
Sciences Clients Worldwide
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
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