Tuesday 7 January 2020

BPOM RI /FDA Consulting Our pharma division can assist you with the registration of products across different categories such as cosmetics, drugs and food

The Food and Drug Administration (BPOM RI) Indonesia  division for all food, drug, cosmetic, medical, and all related products. The BPOM RI/ FDA is responsible for ensuring the safety, purity, and quality of all products relating to food, drugs, cosmetics, medical devices, and household hazards that are available in the Indonesia market. The FDA is also tasked to regulate the production, sale, and traffic of said products to protect the health and safety of the people.

One of the main functions of FDA is to issue a License to Operate to establishments as importer, distributor, wholesaler, or manufacturer of food, drugs, cosmetics and medical devices  with technical requirements in compliance to their regulations. Products are issued a Certificate of Product Registration (MD/ML/NIE).

The BPOM RI/ FDA is also responsible for the approval and monitoring of Clinical Trials in the Indonesia. Companies wishing to introduce new and innovative products must first register with FDA, after which they will be granted a temporary CPR for use during the clinical trial; a closely monitored process which requires regular reporting.

we can assist your company in processing and obtaining LTOs and CPRs from FDA, as well as offer services for investors and entrepreneurs looking to do business in the Food, Cosmeceutical and Pharmaceutical Industries in the Indonesia.
Services provided:

    Orientation to the proper processes and procedures in applying for company and product registration.
    Guidance in the preparation of all necessary documents to avoid rejection and minimize submission of incomplete documents.
    Acquisition of approved applications by monitoring the step-by-step process necessary for ratification.


Contact Use 081287864928
ari_aliest@yahoo.co.id

Jasa Pendaftaran BPOM RI

Administrasi Makanan dan Obat-obatan (BPOM) Indonesia, sebagai divisi pengaturan dan penegakan untuk semua makanan, obat-obatan, kosmetik, medis, dan semua produk terkait. BPOM RI bertanggung jawab untuk memastikan keamanan, kemurnian, dan kualitas semua produk yang berkaitan dengan makanan, obat-obatan, kosmetik, peralatan medis, dan bahaya rumah tangga yang tersedia di pasar Indonesia. BPOM RI juga bertugas mengatur pengawasan produksi, penjualan, dan lalu lintas produk-produk tersebut untuk melindungi kesehatan dan keselamatan manusia.

Salah satu fungsi utama BPOM RI adalah mengeluarkan Lisensi untuk Beroperasi pada perusahaan sebagai importir, distributor, grosir, atau produsen makanan, obat-obatan, kosmetik, dan perangkat medis dengan persyaratan teknis sesuai dengan peraturan mereka. Produk mengeluarkan Sertifikat Pendaftaran Produk (MD, NIE) sebelum dapat memasuki pasar Indonesia, dan harus mematuhi persyaratan teknis dan standar identitas yang direkomendasikan, keamanan, kemurnian dan kualitas yang ditetapkan oleh BPOM.

BPOM RI juga bertanggung jawab atas persetujuan dan pemantauan Uji Klinis di Indonesia. Perusahaan yang ingin memperkenalkan produk baru dan inovatif harus terlebih dahulu mendaftar ke BPOM RI.


    Kami melayani Orientasi ke proses dan prosedur yang tepat dalam mengajukan permohonan pendaftaran perusahaan dan produk.
    Bimbingan dalam persiapan semua dokumen yang diperlukan untuk menghindari penolakan dan meminimalkan penyerahan dokumen yang tidak lengkap.
    Akuisisi aplikasi yang disetujui dengan memantau proses langkah demi langkah yang diperlukan untuk ratifikasi

Hubungi kami 081287864928

FDA/ BPOM Registration Services in the INDONESIA

Foreign investors and enterprises that intend to do business in the Food, Pharmaceutical or Cosmeceutical industries in the INDONESIA are required to register their products with the Food and Drug Administration (FDA/BPOM Republic Indonesia). The registration requirements and processing timelines depend on the classification of the products to be marketed, which could be any of the following:
  • food;
  • food supplements;
  • drugs;
  • cosmetics;
  • household hazardous;
  • pesticides;
  • medical devices;
  • diagnostics; or
  • veterinary products.
Before these products can be imported, exported, distributed, marketed, advertised or manufactured in and out of the Indonesia, a foreign investor or company must first secure a License to Operate (LTO) from the FDA/BPOM as: (1) Importer, Distributor or Wholesaler if their products are going to be imported from different countries; or as (2) Manufacturer if their products are going to be manufactured locally.
After obtaining an LTO, they must apply for a Certificate of Product Registration (CPR) to have their products examined and officially registered with the FDA/BPOM. Product licensing and certification from the FDA/BPOM is required by law under Republic Act No.36 Tahun 2009 and is strictly regulated.
The FDA/BPOM is tasked to regulate the production, sale, and traffic of products allowed entry into the Indonesia market to protect public health and safety, and it is important to secure LTO and CPR from this agency not only to comply with Indonesia laws but also to increase the credibility of your product/s through the assurance of food safety and ethical practice in the medical trade.
Our FDA/BPOM registration experts will help you obtain the right type of licenses for your product/s and will work with appropriate government agencies to help you stay on top of rules and regulations imposed by the FDA/BPOM on regulated products in the Indonesia.


for consultancy services and FDA / BPOM permit registration 
Contact use ari_aliest@yahoo.co.id 081287864928