Freyr Sri Lanka

Freyr Sri Lanka is a global regulatory leader providing services and solutions to life sciences companies across over 120 countries. The company specializes in helping clients register products with the National Medicines Regulatory Authority (NMRA) in Sri Lanka. They support activities such as new product applications, manufacturing site registration, sample import licensing, and ongoing product maintenance. Their services cover medicinal products, medical devices, food and food supplements, and cosmetics industries.

The company offers a range of regulatory services including end-to-end pharmaceutical product registration and authorized local representation. They also provide manufacturing site registration support and sample import license assistance. Freyr handles the compilation and submission of dossiers to the NMRA and manages query support until approval is granted. Additionally, they offer ad-hoc regulatory affairs consultation and pharmaceutical lifecycle management support.

Freyr Sri Lanka serves companies in the medicinal products, medical devices, food and food supplements, and cosmetics industries. They assist life sciences companies in their local to global journey by supporting regulatory strategy and market intelligence. The company also provides in-country representation and post-market surveillance functions for clients. Their regulatory software solutions cover the complete NMRA registration life cycle.

The company is part of Freyr's global network with a presence in over 120 countries. They are ISO 9001 and ISO 27001 certified, demonstrating their commitment to quality and information security management. Freyr Sri Lanka operates under the NMRA ACT, No. 5 of 2015, which governs the regulation and control of medicines in Sri Lanka. Their strategic regulatory partnership aims to ensure success for clients navigating the Sri Lankan market.

The company offers flexible regulatory teams that operate across more than 120 countries to support clients globally. They provide tailored regulatory support specifically for the NMRA in Sri Lanka. Freyr also offers consultation for ISO 9001 and ISO 27001 certifications, ensuring compliance with international standards. Their approach allows for customized solutions based on the specific needs of the life sciences company.

Freyr Sri Lanka helps with the registration of medical devices under the NMRA, which falls under the Ministry of Health. They assist with medical device compliance in Sri Lanka and provide authorized local agent support for these registrations. The process includes application submission to the NMRA and query support management until approval is obtained. Translation services are also available to facilitate communication with regulatory bodies.

The company assists with food supplements and dietary supplements, which fall under a borderline category combining characteristics of foods and medicine. According to the NMRA Act No. 05 of 2015, the NMRA is responsible for regulating these products. Freyr provides support for the registration and licensing aspects of these items. They ensure compliance with the specific requirements set forth by the National Medicines Regulatory Authority.

Freyr Sri Lanka provides sample import license support as part of their regulatory services. They also handle the compilation and submission of dossiers to the NMRA for various product types. The company manages query support from the time of submission until final approval. This end-to-end approach ensures that clients have continuous support throughout the registration lifecycle.

The company offers ad-hoc regulatory affairs consultation for clients who need specific expertise on a temporary basis. They also provide pharmaceutical lifecycle management support to handle ongoing compliance and maintenance. Freyr Sri Lanka acts as a strategic regulatory partner to help clients navigate the complex regulatory landscape in Sri Lanka. Their services are designed to support the entire regulatory value chain for life sciences companies.

Freyr Sri Lanka emphasizes its role as a trusted global partner for success in Sri Lanka. They aim to provide end-to-end pharmaceutical product registration services to streamline the process for clients. The company's expertise includes authorized local representation to ensure smooth interactions with the NMRA. Their goal is to facilitate the local to global journey for life sciences companies.

Freyr Sri Lanka operates under the NMRA, which is the key drug regulatory agency in Sri Lanka. The NMRA is responsible for the regulation and control of registration, licensing, manufacturing, importation, and other aspects pertaining to medical devices. Freyr works closely with the NMRA to ensure that all regulatory requirements are met for clients. Their services are tailored to comply with the NMRA ACT, No. 5 of 2015.

Freyr Sri Lanka is located at Colombo, 00700, LK.

You can reach Freyr Sri Lanka by phone at 9084837958.

The official website of Freyr Sri Lanka is freyrsolutions.com.lk.

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