Comprehensive Business Establishment Services for the Healthcare, Manufacturing, and Professional Services Sectors, supported by seasoned experts, ensuring your business operates smoothly and in compliance from the outset.
CPAKB
CPOB
CPPKRTB
CDAKB
Regulatory Consultation
Comprehensive Business Establishment Services for the Healthcare, Manufacturing, and Professional Services Sectors, supported by seasoned experts, ensuring your business operates smoothly and in compliance from the outset.
Accelerate your market access through an efficient and standardized licensing process, while proactively ensuring regulatory compliance. With an industry best-practice approach and proven methodology, you gain a competitive advantage without compromise.
Licensed corporate nominee services ensuring local ownership compliance and governance continuity.
Real-time digital reporting platform for regulatory submissions and audit readiness in a single dashboard.
End-to-end services from customs clearance and document completion to compliance verification, speeding up market access.
We assist in implementing the Ministry of Health's EWATCH system to ensure digital compliance for health facilities.
Standardized warehousing with temperature control and inventory management for timely distribution and regulatory inspections.
We provide extensive product registration services to guarantee that your products adhere to all regulatory standards and market requirements. Our offerings are tailored to streamline the compliance process and expedite your product's market entry.
National
International
National
Domestic Medical Equipment
International Medical Devices
International Health Supplies
Food and Drug Administration - USA
Digital Authorization Code
Indonesian National Standard
International
Conformite Europeenne
UK Conformity Assessed
UK
Food and Drug Administration - USA
Unique Device Identification
Canadian Medical Device Regulations
Central Drugs Standard Control Organization - India
Certification support spanning enterprise ISO standards, hospital ISO standards, TKDN and BMP facilitation, and intellectual property protection.
ISO Series Enterprise
ISO Series Hospital
ISO Series - Enterprise
ISO Standard
ISO Standard
Determine the requirements for establishing, implementing, maintaining, and continuously improving an information security management system within an organizational context.
ISO Standard
Supports medical laboratories in establishing quality and competence systems that improve reliability, patient safety, and confidence in diagnostic results.
ISO Standard
An organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer needs and applicable regulatory requirements. This includes the design and development, manufacture, storage and distribution, installation, or servicing of medical devices.
ISO Standard
Assist organizations in implementing an anti-bribery management system and provide assurance to management, organization owners, shareholders, customers, and other business partners.
ISO Standard
Demonstrate a real commitment to global food safety that ensures proper consumption of food and beverages so as to gain the trust of national & international customers.
ISO Standard
Useful for doing tests, sampling or calibration, and want reliable results. This includes all types of laboratories, whether owned and operated by the government, industry, or other organizations.
ISO Standard
Helps save costs in handling waste and reduces negative impacts on the environment due to operational activities such as waste pollution and efficiency of energy resources. This will improve the company's image from a public perspective and strengthen relations with regulators, investors, and potential creditors.
ISO Standard
Able to reduce the number of workplace accidents as well as take into account the risks and hazards so as to strive for continuous improvement. Also, there are legal and other requirements related to the OSH management system.
ISO Standard
ISO Standard
In order to increase customer trust and satisfaction, as well as motivate employees and create a culture of continuous improvement and improve product and process quality assurance.
ISO Standard
Helps save costs in handling waste and reduces negative impacts on the environment due to operational activities such as waste pollution and efficiency of energy resources. This will improve the company's image from a public perspective and strengthen relations with regulators, investors, and potential creditors.
ISO Standard
Able to reduce the number of workplace accidents as well as take into account the risks and hazards so as to strive for continuous improvement. Also, there are legal and other requirements related to the OSH management system.
ISO Standard
Useful for doing tests, sampling or calibration, and want reliable results. This includes all types of laboratories, whether owned and operated by the government, industry, or other organizations.
ISO Standard
Determine the requirements for establishing, implementing, maintaining, and continuously improving an information security management system within an organizational context.
ISO Standard
Supports medical laboratories in establishing quality and competence systems that improve reliability, patient safety, and confidence in diagnostic results.
ISO Standard
Assist organizations in implementing an anti-bribery management system and provide assurance to management, organization owners, shareholders, customers, and other business partners.
ISO Standard
Demonstrate a real commitment to global food safety that ensures proper consumption of food and beverages so as to gain the trust of national & international customers.
ISO Standard
Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and healthcare facility settings.
ISO Standard
To set a process for manufacturers to identify the hazards associated with medical devices, including in vitro diagnostic medical devices (IVD), to estimate and evaluate the risks to those products, to control these risks, and to monitor the effectiveness of controls.
TKDN (Tingkat Komponen Dalam Negeri) - Domestic Component Level
We provide support in the processing and facilitation of TKDN and BMP certification, ensuring that your products or services adhere to government regulations, enhance competitiveness, and navigate the application process efficiently until the issuance of the certificate, in accordance with the latest provisions.
HAKI (Hak Kekayaan Intelektual) - Intellectual Property Rights (IPR)
We facilitate the management and safeguarding of intellectual property rights (IPR) to ensure that your creations, brands, and innovations are legally protected, add value, and are registered efficiently, swiftly, and securely in accordance with Indonesian regulations.
Quality Improvement Program for Hospitals offers various certification and training services that enhance the capability and skills of management and all hospital personnel in supporting the quality and operation of the hospital, since it directly affects the effectiveness of operations, patient satisfaction, healthcare service quality, and overall facility success.
Training Registration FormISO Certification
ISO 9001 - 2015
ISO 11135 - 2014
ISO 45001 - 2018
ISO 27001 - 2022
ISO 14001 - 2015
ISO 22000 - 2018
ISO 37001 - 2016
ISO 13485 - 2016
ISO 14971 - 2013
ISO 17025 - 2017
