Greetings from Freyr ThailandFreyr is a global Regulatory leader providing services and solutions to Life Sciences companies in their entire Regulatory value chain. At Freyr Thailand, we support companies to register their products with the Thai FDA, Regulatory strategy, market intelligence, in-country representation, PMS functions, and more. We also offer next-gen Regulatory software solutions covering the complete Thai FDA registration life cycle. The Agency regulates pharmaceutical product registration in Thailand. With updated Regulatory intelligence over the new Regulatory system of Thailand, Freyr assists new market entrants to keep pace with the evolved Regulatory requirements related to registrations, dossier compilation, and submissions for the necessary market authorizations.

To help companies in the chemical industry meet these compliance requirements, Freyr offers a comprehensive range of chemical regulatory compliance management services. Freyr provides comprehensive compliance management services to help companies streamline their compliance activities and ensure continued adherence to regulatory requirements. Our compliance management solutions include the development and implementation of compliance programs tailored to the specific needs of our clients. In conclusion, chemical regulatory compliance is a complex and critical aspect of the chemical industry. Freyr's comprehensive range of chemical regulatory compliance management services can assist companies in meeting these requirements effectively.

With regional offices in Europe, North America, MENA and APAC regions and with a vast partner network spanning 120 countries, We help manufacturers, distributors and marketers of finished products and raw materials worldwide in areas of Regulatory Intelligence. We also provide tailored / on-demand reports to support our clients and assists them in navigating through various procedural complexities pertaining to product classification, registration and process clearances to enhance the regulatory pathway. The cloud-hosted Regulatory intelligence software, Freyr IMPACT effectively monitors, collects and updates various industrial information by analyzing current regulations, guidance, policies, and legislations. Features & Highlights:Regulatory reporting and tracking softwareAbility to store and archive information and supporting documentsAssign actions, discuss, collaborate and share information on new updatesAssured data securityEXPLORE NOWExpert Intelligence reports to facilitate Regulatory decision-making and support compliance and strategic business growth. The reports are:Comprehensive and conciseCost and time effectiveArticulated by the industry expertsCustomized as per various regional Regulatory standards

The system has options for authoring at ‘Document Level’ and ‘Component Level’; each having its own significance and ease in label development. The users can either choose Document Level Authoring or Component Level Authoring to develop their labels availing Freyr LABEL 360. Supporting documents like illustrations and journals can be uploaded and linked to the documents, which can be associated with documents created in future. With Component Level Authoring, ‘dynamic’ label comparisons of different components can be done, at any given point in time. With this integration, tracking dates of the document are generated based on the progress of the document within label management.

Greetings from Freyr Sri LankaFreyr is a global Regulatory leader providing services and solutions to Life Sciences companies in their entire Regulatory value chain. With our presence in 120+ countries, we help Life Sciences companies in their “local to global” journey. At Freyr Sri Lanka, we support companies to register their products with the NMRA, Regulatory strategy, market intelligence, in-country representation, PMS functions, and more. We also offer next-gen Regulatory software solutions covering the complete NMRA registration life cycle. Freyr ExpertiseEnd-to-end Pharmaceutical Product RegistrationAuthorized Local RepresentationNMRA Manufacturing Site RegistrationSample Import License SupportQuery Support Management till ApprovalPharmaceutical Lifecycle Management SupportAd-hoc Regulatory Affairs ConsultationKnow MoreIndustries We ServeMedicinal ProductsMedical DevicesFood and Food SupplementsCosmeticsNMRA is the key drug Regulatory Agency in Sri Lanka.

This is where food regulatory consulting firms, such as Freyr, come into play. Understanding Food Regulatory Compliance Consulting:Food regulatory compliance consulting involves obtaining guidance and support from experts who specialize in food regulations and compliance. Benefits of Food Regulatory Compliance Consulting:Engaging a food regulatory compliance consulting firm like Freyr can bring numerous benefits to food and dietary supplement manufacturers:1. Services Offered by Freyr:Freyr provides a comprehensive range of food regulatory consulting services to support food and dietary supplement manufacturers. Conclusion:Food regulatory compliance consulting plays a crucial role in helping food and dietary supplement manufacturers meet the necessary regulations and standards.

Overview of the MexicanRegulatory LandscapeFederal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios), popularly known as COFEPRIS, is the National Health Authority in Mexico. It is responsible for production, distribution, commercialization, imports and exports, advertisement, sales, and supply of these products. OverviewThe “Comisión Federal para la Protección Contra Riesgos Sanitarios” (COFEPRIS) is the key Drug Regulatory Authority in Mexico. Classification of Medicinal ProductsMedicinal products are classified into following categories.  C) Waiver of Onsite GMP InspectionOnsite GMP inspection can be waived if the manufacturing facility is approved by a COFEPRIS recognized entity: Health Canada, US FDA, EMA, the Pharmaceutical and Food Safety Bureau (PFSB) of Japan, the Australian Therapeutic Goods Administration or another entity recognized by COFEPRIS.

Freyr provides United Kingdom Responsible Person (UKRP) services to foreign medical device manufacturers in product registration and market entry in the UK and acts as a single point of contact in the Country for liaison with Regulatory Agency. Freyr provides United Kingdom Responsible Person (UKRP) services to foreign medical device manufacturers in product registration and market entry in the UK and acts as a single point of contact in the Country for liaison with Regulatory Agency. Freyr provides United Kingdom Responsible Person (UKRP) services to foreign medical device manufacturers in product registration and market entry in the UK and acts as a single point of contact in the Country for liaison with Regulatory Agency. Freyr provides United Kingdom Responsible Person (UKRP) services to foreign medical device manufacturers in product registration and market entry in the UK and acts as a single point of contact in the Country for liaison with Regulatory Agency. Freyr provides United Kingdom Responsible Person (UKRP) services to foreign medical device manufacturers in product registration and market entry in the UK and acts as a single point of contact in the Country for liaison with Regulatory Agency.

Greetings from Freyr IndiaFreyr is a global Regulatory leader providing services and solutions to Life Sciences companies in their entire Regulatory value chain. With our presence in 120+ countries, we help Life Sciences companies in their “local to global” journey. At Freyr India, we support companies to register their products with the CDSCO, Regulatory strategy, market intelligence, in-country representation, PMS functions, and more. We also offer next-gen Regulatory software solutions covering the complete CDSCO registration life cycle. Freyr provides a variety of Regulatory affairs services and Regulatory affairs consulting.

Freyr iREADY is a technology based Cosmetic Ingredient Database platform and it provides Regulatory compliance support to manufacturers for cosmetics ingredients and management of product formulae in global markets. With growing scientific knowledge and sensitivity towards product safety, the consumer industry is witnessing more mature and stringent guidelines by the Health Agencies to ensure consumer safety. Sometimes, changes in regulations by the Health Agencies causes huge impact on the existing products of an organization, for instance, preservatives (MIT and CIT) are now banned from many consumer products and if the awareness on the same is delayed, it could lead to reformulation, product recalls, and/or heavy penalty due to non-complianceFreyr iREADY helps companies determine the existing products that would have an impact due to an ingredient change, that in turn will be beneficial for accurate decision-making. It is even useful during product development as it enables R&D teams to study the impact of change in ingredient regulation on product formulae, or at times when the Regulatory Authority prohibits the use of certain ingredients in a specific market. With growing scientific knowledge and sensitivity towards product safety, the consumer industry is witnessing more mature and stringent guidelines by the Health Agencies to ensure consumer safety. Sometimes, changes in regulations by the Health Agencies causes huge impact on the existing products of an organization, for instance, preservatives (MIT and CIT) are now banned from many consumer products and if the awareness on the same is delayed, it could lead to reformulation, product recalls, and/or heavy penalty due to non-complianceFreyr iREADY helps companies determine the existing products that would have an impact due to an ingredient change, that in turn will be beneficial for accurate decision-making. It is even useful during product development as it enables R&D teams to study the impact of change in ingredient regulation on product formulae, or at times when the Regulatory Authority prohibits the use of certain ingredients in a specific market.

Uniquely positioned with label content and artwork design expertiseFreyr is a dedicated artwork services provider for entire life sciences sector – Pharmaceuticals, Medical Devices, Cosmetics, and Consumer Healthcare. It requires Life Sciences companies to address concerns of cost management and savings. Especially with Artwork Lifecycle Management, companies should look for methods to optimize all processes including the packaging artwork process. Either through manual coordination or through Artwork PLM tool integration, intricacies in activities remain the same. Eventually, it is the responsibility of the artwork lifecycle management manager (Artwork Lifecycle management Coordination manager) to ensure that the designs are done on time for a smooth product launch.

Freyr provides End-to-End Post Brexit regulatory support for Pharma, Medical Devices, Cosmetics and Food Supplements manufacturers who are willing to market their products in United Kingdom (UK) and EU. Freyr provides End-to-End Post Brexit regulatory support for Pharma, Medical Devices, Cosmetics and Food Supplements manufacturers who are willing to market their products in United Kingdom (UK) and EU. Freyr provides End-to-End Post Brexit regulatory support for Pharma, Medical Devices, Cosmetics and Food Supplements manufacturers who are willing to market their products in United Kingdom (UK) and EU. Freyr provides End-to-End Post Brexit regulatory support for Pharma, Medical Devices, Cosmetics and Food Supplements manufacturers who are willing to market their products in United Kingdom (UK) and EU. Freyr provides End-to-End Post Brexit regulatory support for Pharma, Medical Devices, Cosmetics and Food Supplements manufacturers who are willing to market their products in United Kingdom (UK) and EU.

Greetings from Freyr AustraliaFreyr is a global Regulatory leader providing services and solutions to Life Sciences companies in their entire Regulatory value chain. At Freyr Australia, we support companies to register their products with the TGA, Regulatory strategy, market intelligence, in-country representation, PMS functions, and more. We also offer next-gen Regulatory software solutions covering the complete TGA registration life cycle. New UpdateRegulatory Support for TGA eCTD SubmissionsStarting November 01, 2021, the Therapeutic Goods Administration (TGA) will begin a phased transition to Electronic Common Technical Document-only (eCTD-only) for all prescription medicines. For distribution or marketing of medicinal products or drugs in Australia, manufacturers must obtain approval from the Therapeutic Goods Administration (TGA), the body responsible for enabling pharmaceutical products registration in Australia.

Freyr provides Regulatory services and solutions in Saudi Arabia to comply with SFDA regulations for pharmaceuticals, medical devices, cosmetics and food supplements manufacturing companies.

The new Structured Product Monograph is based on Extensible Markup Language (XML), Health Level 7’s (HL7) Structured Product Label (SPL) standard and controlled vocabularies. Based on extensible markup language (XML) the SPM format facilitates the communication of drug labeling data reliability among various groups such as hospitals, prescribing organizations, and doctors, in addition to the general public through Canada Product Database. The header includes information about the document such as the type of product and company information and details about its versioning. The body of the document includes product information in both structured with section and subsections in it. Would you like to understand the basic structure of an SPM format?

Freyr provides end to end regulatory support for medical device & IVD manufacturers in product registration, notification, classification across the globe. Freyr provides end to end regulatory support for medical device & IVD manufacturers in product registration, notification, classification across the globe. Freyr provides end to end regulatory support for medical device & IVD manufacturers in product registration, notification, classification across the globe. Freyr provides end to end regulatory support for medical device & IVD manufacturers in product registration, notification, classification across the globe. Freyr provides end to end regulatory support for medical device & IVD manufacturers in product registration, notification, classification across the globe. Freyr provides end to end regulatory support for medical device & IVD manufacturers in product registration, notification, classification across the globe.