Our Services

At Alphamed, we offer a comprehensive suite of regulatory consulting services designed to streamline your path to market and ensure sustained compliance in the medical device and healthcare sectors. We understand the intricacies of global regulations and provide tailored solutions to meet your specific needs. Our expertise spans the entire product lifecycle, from initial concept to post-market surveillance.

1.

Product Registration Services

We assist clients in obtaining market authorization for medical device and healthcare products by expertly managing the full registration process. Our comprehensive Product Registration Services navigate complex global regulations, from initial documentation and dossier preparation to submission and agency liaison. We streamline every step, ensuring compliance and accelerating your product’s journey to market entry.

AKL
AKD
Cosmetic Notification

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2.

Permit and Certification

We specialize in Permit and Certification services, guiding companies through the intricate process of securing essential operational licenses and facilities certifications. This ensures you can legally manufacture, distribute, or import medical devices without hindrance. From quality management system certifications to site-specific permits, our expertise minimizes regulatory hurdles, enabling compliant and efficient market operations for your medical products.

CDAKB
CPAKB
CPPKRTB
CDOB
HALAL

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3.

License Holding

Acting your as your license holder official license holder in Indonesia, we help foreign medical device manufaturers enter the local market without the need establish a local entity. As your trusted in-country representative, we ensure regulatory compliance, manage product registrations, and coordinate with the Ministry of Health on your behalf-so you can focus on global operations.

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4.

Quality Management System (ISO)

We help establish, implement, and maintain robust Quality Management Systems (QMS) in accordance with ISO standards, such as ISO 13485 for medical devices. Our services ensure your operations consistently meet regulatory requirements and industry best practices. From gap analysis and documentation development to employee training and internal audits, we provide comprehensive support to achieve and sustain ISO certification, fostering a culture of quality and continuous improvement within your organization.

ISO 9001 : Quality Management System
ISO 14001 : Environtmental Management System
ISO 45001 : OSH Management System
ISO 13485 : Medical Devices Quality Management System
ISO 27001 : Information Security Management System
ISO 37001 : Anti-Bribery Management System
ISO 17025 : Testing and Calibration Laboratories
ISO 15189 : Medical Laboratories
ISO 22000 : Food Safety Management System