Our Services | CDOB, CPOB, ISO, WHO GDP Certification & Licensing (60 characters)

Our Services

CDOB CERTIFICATION (GOOD DISTRIBUTION PRACTICES FOR PHARMACEUTICALS)

Providing CDOB Certification Assistance Services for Medicines, Pharmaceutical Ingredients, Cold Chain Products, and Other Pharmaceutical Products.

According to Regulation No. 9 of 2019 by the Indonesian Food and Drug Authority (BPOM), CDOB refers to the method of distributing/channeling medicines and/or pharmaceutical ingredients to ensure quality throughout the distribution/supply chain in accordance with requirements and intended use.

Pharmaceutical Wholesalers (PBF), PBF Branches, and Pharmaceutical Preparation Installations are required to implement TECHNICAL GUIDELINES FOR CDOB in the procurement, storage, and distribution of medicines, as evidenced by a CDOB CERTIFICATE.

CPOB CERTIFICATION (GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICALS)

Providing CPOB Certification Assistance Services for Pharmaceutical Companies.

According to Regulation No. HK.03.1.33.12.12.8195 of 2012 by the Head of the Indonesian Food and Drug Authority (BPOM), CPOB refers to the method of manufacturing medicines to ensure that the quality of the produced medicines meets the requirements and intended use.

Pharmaceutical Industries, in all aspects and stages of the manufacturing process of medicines and/or pharmaceutical ingredients, are required to implement CPOB Guidelines, as evidenced by a CPOB CERTIFICATE.

ISO 9001:2015 CERTIFICATION

Providing ISO 9001:2015 Certification Assistance Services.

ISO 9001 is the most widely used Quality Management System in the world.

All requirements of ISO 9001:2015 are global and applicable to any organization.

ISO 9001:2015 sets the requirements for a quality management system when an organization:

Needs to demonstrate its ability to consistently provide products and services that meet customer satisfaction as well as comply with applicable legal and regulatory requirements,

Aims to enhance customer satisfaction through the implementation of an effective and consistent system, continually improving the system to always meet applicable legal and regulatory requirements.

WHO GSDP CERTIFICATION (GOOD STORAGE AND DISTRIBUTION PRACTICES)

Providing WHO GSDP Certification Assistance Services.

Storage and distribution are critical activities in ensuring the equitable supply of medical products across all regions

Medical products can face various potential risks during the distribution phase, including procurement, storage, distribution, transportation, repackaging, and more.

Substandard and counterfeit products pose significant threats to public health and safety, making GSDP essential to protect the public from such risks.

PHARMACEUTICAL LICENSING AND PRODUCT REGISTRATION SERVICES

Providing services for managing licenses related to the pharmaceutical field, such as pharmaceutical manufacturing licenses, pharmaceutical distribution licenses, as well as the registration process for pharmaceutical products, including medicines, supplements, cosmetics, traditional medicines, and medical devices.

TRAINING AND CONSULTATION SERVICES RELATED TO GMP AND GDP

We provide training and consultation services related to GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) in their day-to-day applications, such as qualification, validation, documentation systems/procedures, and preparing reports in accordance with GMP and GDP principles.

LICENSING SERVICES AT THE INDONESIAN FOOD AND DRUG AUTHORITY (BPOM RI)

Import Certificate (SKI - Surat Keterangan Impor)

Analysis of Monitoring Results (AHP - Analisa Hasil Pengawasan)

LICENSING SERVICES FOR SPI AND PI AT THE MINISTRY OF HEALTH RI

Import Permit for Pharmaceuticals (SPI - Surat Persetujuan Impor)

Pharmaceutical Import License (PI - Izin Impor)

MASTERLIST OF MACHINERY PROCESSING SERVICES AT BKPM RI

Providing services for managing the Masterlist of Machinery at the Investment Coordinating Board of the Republic of Indonesia (BKPM RI).