Professional BPOM Pharmaceutical Product Registration
made Easier with Us
Navigate complex pharmaceutical regulations with our professional assistance. BPOM pharmaceutical authorization provides official validation of a health product's efficacy, safety, and quality and is essential for distribution through pharmacies and hospitals across Indonesia.
What Is BPOM Pharmaceutical Authorization?
BPOM pharmaceutical authorization is the official marketing authorization issued by Indonesia's Food and Drug Authority after a comprehensive evaluation of safety, efficacy, and quality. Awan Kusuma assists with marketing authorization for modern medicines, traditional medicines (jamu), and health supplements, including CPOB or CPOTB compliance, variation registration, and issuance of the Marketing Authorization Number (NIE).
WHY IS BPOM PHARMACEUTICAL AUTHORIZATION IMPORTANT FOR YOUR BUSINESS?
Pharmacological Safety and Patient Protection
Medicinal products without BPOM authorization may present risks involving harmful active substances or incorrect dosage. We help ensure formulation and stability evidence satisfies the applicable evaluation requirements, reducing patient-safety and legal risks.
Mitigating Authorization Revocation and Serious Legal Sanctions
Non-compliance with pharmaceutical standards may result in a nationwide product recall, business-license revocation, or criminal sanctions. Precise registration and pharmacovigilance monitoring help protect pharmaceutical investments from costly administrative enforcement.
Access to Pharmaceutical and Healthcare Distribution Channels
A Marketing Authorization Number (NIE) is required before a product may be prescribed by healthcare professionals, supplied through pharmacies and hospitals, or considered for national medicine procurement. We streamline preparation of technical documentation to support broader market access.
Greater Scientific Credibility and Global Competitiveness
BPOM information on pharmaceutical packaging is an important trust signal for healthcare professionals and the public. Transparent compliance strengthens scientific credibility and supports a professional reputation in a highly regulated global healthcare industry.
Simple in
4 Steps
A simple, transparent, and hassle-free process. We handle the administrative complexity so you can focus on growing your business.
Free Consultation
Discuss your business needs with our expert team.
Submit Documents
Send the required documents securely online.
Application Process
Our legal team handles the process with the relevant authorities.
Documents Completed
Your official documents are completed and delivered to you.
Choose Your Package
Transparent pricing with no hidden fees. Build a strong legal foundation for your business with Awan Kusuma.
BPOM Registration
Indonesian Food and Drug Authority (BPOM)
- Assistance with product registration at BPOM
- Review of required documents
- Consultation on product labeling and formulation
- Company Documents
- Halal Certificate (if a halal claim is made)
- Product ingredient composition
- COA (Certificate of Analysis)
- Product samples for laboratory testing
- Production Business License (SIUP)
- Good Manufacturing Practice Certificate (CPB)
BPOM Add-Ons
BPOM Registration + Account Management Assistance
- Assistance with product registration at BPOM
- Review of required documents
- Consultation on product labeling and formulation
- Account Management Assistance
- Company Documents
- Halal Certificate (if a halal claim is made)
- Product ingredient composition
- COA (Certificate of Analysis)
- Product samples for laboratory testing
- Production Business License (SIUP)
- Good Manufacturing Practice Certificate (CPB)
Real Proof of
Trust
First-hand experiences from clients who have used our BPOM Pharmaceutical Product Registration service.
"I have always been satisfied with Awan Kusuma's services. Their team handled my business licensing issues professionally and provided valuable insight and guidance for future licensing matters, helping my business operate smoothly."
Feli
Client
"During my time using your services, everything was truly pleasant and easy to work with. They were responsive, communicative, and all my needs were handled well and on time. Most importantly, they were incredibly trustworthy, which gave me peace of mind throughout the process. Thank you for helping me handle everything. If I have any more legal needs in the future, I'll definitely use your services again."
Misshell
Client
"The service from the Awan Kusuma Legalitas Team has been very helpful for a layperson like me in determining the type of business allocation. They are very capable and professional. Thank you, Awan Kusuma Legalitas."
Rudy
Client
Contact Us
Have a specific question about our BPOM Pharmaceutical Product Registration service?
Frequently Asked
Questions
Find quick answers to common questions about BPOM Pharmaceutical Product Registration.
The company must hold the relevant pharmaceutical license, whether as a pharmaceutical manufacturer or PBF distributor, and an applicable CPOB Good Manufacturing Practice certificate. Without the required quality-system certification, an NIE application cannot be processed.
Pharmaceutical registration involves complex risk classification and rigorous technical-data verification. Professional regulatory assistance helps align administrative, technical, and formulation documents with current requirements, reducing the risk of rejection or evaluator queries.
Evaluation time varies by product category, including new drugs, generics, and variations. The regulatory timeline generally ranges from 100 to 300 working days after the dossier is declared complete and passes pre-registration, subject to evaluator queries and applicable rules.
