9001:2015
ISO 9001 - 2015
ISO Standard
Quality Management System
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.
Inspiry Thinks
Set up New Business
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.
Business Permit
KBLI Classification
Notarial Instrument
Residence Permit
Business License Number
Tax Registration
Operating Permit
01
Hospital License
02
Clinic License
03
Laboratory License
04
Medical Device Manufacturing License
05
Medical Device Distribution License
06
Cosmetics License
07
Pharmaceutical Wholesaler License
Management Practice
CPB Alkes
CPB Obat
CPB PKRT
CDB Alkes
CDB Obat
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.
Inspiry Thinks
License Holding
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.
01
License Holder
Licensed corporate nominee services ensuring local ownership compliance and governance continuity.
02
E-Report
Real-time digital reporting platform for regulatory submissions and audit readiness in a single dashboard.
03
Import Services & Consultation
End-to-end services from customs clearance and document completion to compliance verification, speeding up market access.
04
E-Watch
We assist in implementing the Ministry of Health's EWATCH system to ensure digital compliance for health facilities.
05
Warehouse Services & Consultation
Standardized warehousing with temperature control and inventory management for timely distribution and regulatory inspections.
Inspiry Thinks
Product Registration
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
Domestic Medical Device
AKD
International Medical Device
AKL
Registration Number for Local Products
PKD
Registration Number for Imported Products
PKL
Digital Authorization Code
NIE
Indonesian National Standard
SNI
Halal Certification
International
CE Mark
Conformite Europeenne
UKCA
UK Conformity Assessed
MHRA
UK
FDA
Food and Drug Administration - USA
UDI
Unique Device Identification
CMDR
Canadian Medical Device Regulations
CDSCO
Central Drugs Standard Control Organization - India
Inspiry Thinks
Certification
Certification support spanning ISO standards, TKDN, SNI, BMP facilitation, and intellectual property protection.
ISO Series
14001:2015
ISO 14001 - 2015
ISO Standard
Environmental Management System
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.
45001:2018
ISO 45001 - 2018
ISO Standard
Occupational Health and Safety Management System
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.
27001:2022
ISO/IEC 27001 - 2022
ISO Standard
Information Security, Cybersecurity & Privacy Protection
Determine the requirements for establishing, implementing, maintaining, and continuously improving an information security management system within an organizational context.
17025:2017
ISO/IEC 17025 - 2017
ISO Standard
Testing and Calibration Laboratory Competence
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.
15189:2012
ISO 15189 - 2012
ISO Standard
Medical Laboratory Quality and Competence
Supports medical laboratories in establishing quality and competence systems that improve reliability, patient safety, and confidence in diagnostic results.
37001:2016
ISO 37001 - 2016
ISO Standard
Anti-Bribery Management Systems (ABMS)
Assist organizations in implementing an anti-bribery management system and provide assurance to management, organization owners, shareholders, customers, and other business partners.
22000:2018
ISO 22000 - 2018
ISO Standard
Food Safety Quality Management System
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.
13485:2016
ISO 13485 - 2016
ISO Standard
Medical Devices Quality Management Systems
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.
TKDN
TKDN (Tingkat Komponen Dalam Negeri) - Domestic Component Level
Support for TKDN certification so products and services can meet domestic component requirements and strengthen competitiveness in procurement.
SNI
SNI (Standar Nasional Indonesia) - Indonesian National Standard
Support for Indonesian National Standard certification so products can align with applicable national quality and safety requirements.
BMP
BMP (Bobot Manfaat Perusahaan) - Company Benefit Weight
Support for BMP documentation and facilitation so companies can present local-benefit contributions clearly and consistently.
HAKI
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.
