Freyr Solutions

This report provides information on regulations imposed on In-Vitro Diagnostics (IVD) device in Nigeria as per Nigerian government for product import, registration process, classification, submission, renewal process & variation filing. Summary Product definition and classification criteria; IVD registration process; Precise information on health authority fees, timelines for registration and submission mode (online/in person); Additional information on the validity of registration, renewal process and variation filing Regulations on labeling, claims and advertising; Information on import regulations and the requirement of a local agent; and Explains the bidding regulation set by the Nigerian government. Check out the more details of the report at  Regulatory Report, In-Vitro Diagnostics, Nigeria, IVD Devices Registration

This report provides information on regulations imposed on medical device in Morocco for product registration, import permit, validity & renewal process, variations filing, legal representative and labeling. Summary Product definition and governing regulations; Information on medical device registration; Explains the process of registration through flowcharts; Precise information on health authority fees & timelines for registration; Additional information on the validity of registration, renewal process and variation filing Presents the regulations applicable on labeling; and Describes the information on import regulations, and the requirement of a legal representative. Check out more details at  Medical Device Regulation Report, Morocco, Registration

This report provides information on regulations imposed on Traditional Medicines in Peru, import & product registration, validity & renewal process, variations filing, local agent requirements, contaminants, labeling, advertising, claims and warehouse licensing. Summary Information on the approval or registration process of traditional medicine; Covers details on the documentation and fees required for submission, submission modes (online/in person), qualification of the importer etc; Explains the process of registration in a simple way through flowcharts; Includes the process of registering ingredients that are not listed in Peru; Provides a list of prohibited/restricted ingredients to check formulation compliance; Lists out the limits of contaminants; and Lays down all the regulations governing traditional medicine in Peru. Check out more details of the report at  Traditional Medicines Regulation Report, Peru

This report provides information on regulations imposed on Cosmetics in Pakistan as per DRAP for product registration, Import, renewal process & variations filing, validation, local agent requirements, labeling, ingredients, Advertising & claims. Summary Provides the enlistment process, applicable fee and timelines of cosmetics carried out by the Drug Regulatory Authority of Pakistan (DRAP); Provides additional information on the validity of registration, renewal process and variation filing; Details the import and legal representative requirements; Provides a list of permitted and prohibited ingredients to check if a formulation is compliant with the enforced regulations; Provides the permissible limits of contaminants like heavy metals and microbes; Labeling requirements for cosmetic products; Underlines the advertising regulations that are levied on cosmetic products; and Lists the claims that can be included on the label of a cosmetic product. Check out more...

This report provides information on regulations imposed on Cosmetics in Europe as per EU for Product registration, CPNP Notification, ingredients, labeling, import permit, variation filing, local agent requirements, advertising & claims. Summary Product approval process through CPNP notification; Precise information on fees required for submission, submission modes (online/in person), qualification of the importer etc.; Provides a list of permitted/prohibited and restricted ingredients to check for formulation compliance; Regulations on claims, labeling and advertising; and Information on customs clearance of cosmetics at the port of entry into EU. Check out more details of the report at  Cosmetics Regulatory Report, EU, Registration

This report provides information on regulations imposed on traditional medicines in Brunei import & registration process, variations, application submission, local agent requirements, ingredients, contaminants control, labeling requirements, warehousing. Summary Information on the approval or registration process; Procedure for company registration in Brunei; Covers details on documentation, fees required for submission, submission modes (online/in person), qualification of the importer, etc; Provides a list of permitted/prohibited ingredients to check formulation compliance; Lists out acceptable/unacceptable claims, labeling and advertising regulations; Heavy metals and microbial contamination limits; and Accommodates a brief on custom clearance process. Check out the more details at  Traditional Medicines Regulation Report, Brunei

This report provides information on regulations imposed on traditional medicines in Chile import, product registration, company registration, local agent requirements, ingredients, contaminants control, labeling, advertising & claims, warehousing. Summary Covers details on documentation, fees required for submission, submission modes (online/in person), qualification of the importer etc; Presents the process of registration in a simple way through flowcharts; Provides a list of permitted/prohibited ingredients to check formulation compliance; Lists out acceptable/unacceptable claims, labeling and advertising regulations; Heavy metals and microbial contamination limits; and Accommodates a brief on custom clearance process. Check out the more details of the report at  Traditional Medicines Regulation Report, Chile

This report provides information on regulations imposed on food supplements in Peru for Product registration, Import, submission, renewal process & variation filing, labeling, Claims and Warehouse Licensing Process. Summary Information on approval or registration process; Process for registration of brand office in Peru; Covers details on documentation and fees required for submission, submission mode (online/in person), qualification of the importer, etc.; Provides a list of permitted/prohibited ingredients to check formulation compliance; Information on acceptable/nonacceptable claims and labeling regulations as per the product characteristics or uses; Lists out the limits of contaminants like heavy metals, mycotoxins, pesticide MRLs, etc.; Also accommodates a brief on custom clearance process. Check out the more details of the report at  Food Supplements Regulation Report, Peru

This report provides information on regulations imposed on cosmetics in Canada for product registration process, ingredients & limits, classification, advertising & claims, post marketing authorization, Import regulations and local agent requirements as per Health Canada. Summary Process of registration represented through flowcharts; Precise information on fees required for submission, submission modes (online/in person), documentation, timelines, qualification of the importer etc.; Provides a list of permitted/prohibited and restricted ingredients to check formulation compliance; Advertising, labeling and claims regulations; Limits of contaminants like heavy metals and microbes; Laboratory tests and procedures during the process of registration; and Customs clearance process for cosmetics at the port of entry. Check out the more details of the report at  Cosmetics Regulatory Report, Health Canada

This report provides information on regulations imposed on food supplements in Chile for product import & registration, local agent requirements, ingredients, contaminants control, labeling, Quality & safety, Advertising & claims and ware hosing licensing. Summary Covers details on documentation, fees required for submission, submission modes (online/in person), qualification of the importer etc; Presents the process of registration in a simple way through flowcharts; Provides a list of permitted/prohibited ingredients to check formulation compliance; Lists out acceptable/unacceptable claims, labeling and advertising regulations; Heavy metals and microbial contamination limits; and Accommodates a brief on custom clearance process. Check out the more details of the report at  Food Supplement Regulation Report, Chile

This report provides information on regulations imposed on Food Supplements in Brunei as per BDMCA, import & product registration, renewal process, variations filing, application submission, local agent requirements, contaminants control, labeling requirements, claims, warehousing. Summary Information on the approval or registration process; Procedure for company registration in Brunei; Covers details on documentation, fees required for submission, submission modes (online/in person), qualification of the importer, etc.; Provides a list of permitted/prohibited ingredients to check formulation compliance; Lists out acceptable/unacceptable claims, labeling and advertising regulations; Heavy metals and microbial contamination limits; and Accommodates a brief on custom clearance process. Check out the more details of the report at  Food Supplements Regulation Reports, Brunei, BDMCA

This report provides information on regulations imposed on cosmetic products (beauty and personal care) in Nepal as per DDA for import, product registration, marketing authorization, notification process, variations, labeling, Safety assessment & PIF. Summary Provides Information on the notification process for cosmetics in Nepal; Covers details of documentation and fees required, submission modes (online/in person) and timelines; Documents required for shipment and consignment sampling; Prerequisites for the import of cosmetics to Nepal; Regulations on the labelling of cosmetic products; and Marketing authorization of imported cosmetics. Check out more details of the report at  Cosmetic Products Regulatory Report, Nepal, DDA

This report provides information on regulations imposed on cosmetics in Thailand, import & product registration, notification, business licensing, renewal process, variation filing, local agent requirements, quality & safety, advertising & claims and warehouse licensing. This report is a comprehensive solution for studying end-to-end regulations on cosmetics in Thailand, which has been recognized as one of the most attractive markets for cosmetics. Thailand’s beauty and personal care product market was valued at approximately 4.36 billion USD in 2016, a 6.5% increase over 2015, making it one of the largest in Southeast Asia. The cosmetic market is expected to reach 5.7 billion USD by 2020 with a CAGR of 6.9%. The objective of this report is to provide precise information on the Regulatory landscape of Thailand, so as to enable a Regulatory go-to-market strategy and ensure compliance. Check out more details on the report at   Cosmetic Regulation Report, Thailand,...

This report provides information on regulations imposed on Cosmetics in Morocco for product registration, Import, renewal process & variations filing, validity, local agent requirements, labeling, ingredients, claims. Summary: Product definition and governing regulations; Information on cosmetics registration; Explains the process of registration through flowcharts; Precise information on health authority fees & timelines for registration; Additional information on the validity of registration, renewal process and variation filing; Presents the regulations applicable on labeling; and Describes the information on import regulations, and the requirement of a legal representative. Check out more details at  Cosmetics Regulatory Report of Morocco

This report provides information on regulations imposed on Food & Beverages in chile for Product registration, Import, submission, renewal, variations, local agent requirement, labeling, Claims and Advertising, Contaminants control & Warehousing. Food & Beverages Regulation Report of Chile

This report provides information on regulations imposed on cosmetics in Brunei as per BDMCA for import, cosmetics product registration, local agent & labeling requirements, ingredients, advertising, claims, Good manufacturing practice (GMP),  Post marketing authorization . Cosmetic Regulation Report of Brunei (BDMCA)

This report provides information on regulations imposed on food supplements in UAE for Product classification, registration, submission, renewal process & variation filing, labeling, advertising & claims, local agent requirement and import regulations. Food Supplement Regulatory Report of UAE

This report provides information on regulations imposed on Cosmetics in Peru as per DIGEMID for Import & cosmetics product registration, , validity, renewal process, variation filing, local agent requirement, Ingredients, labeling, advertising & claims. Cosmetics Regulatory Report of Peru

This report provides information on regulations imposed on cosmetics in Singapore as per HAS for cosmetic product registration, import & product notification, renewal, variation, local agent requirements, ingredients, labeling, advertising & claims. Cosmetics Regulatory Report Of Singapore (HAS)

This report provides information on regulations imposed on Generic Products in Brazil as per ANVISA for drug registration process, labeling & bioavailability/bioequivalence study requirements, GCP, GLP, GMP, GDP, Import License, Export Regulations, CMO/CRO. Pharma Regulatory Report of Brazil

This report provides information on regulations imposed on cosmetics in South Korea as per MFDS for Cosmetics product registration, classification, import, variations, local agent requirements, ingredients registration, contaminants control, labeling, warehousing licensing. Cosmetics Regulatory Report of South Korea

This report provides information on regulations imposed on Food & Beverages in Peru for Product registration/Approval process, Import, submission, renewal, variations, local agent requirement, labeling, Claims and Advertising. Food & Beverages Regulation Report Peru

This report provides information on regulations imposed on cosmetics in Brazil as per ANVISA for risk-based Cosmetic Product classification, registration/Notification (Grade I, II), Import requirements, renewal, variations, local agent requirements, ingredients, warehousing. Cosmetics Regulatory Report of Brazil

This report provides information on regulations imposed on Cosmetics in Chile as per ISP registration, Import, renewal process & variations filing, validity, local agent requirements, labeling, ingredients, contaminations control, quality & safety and warehousing. Cosmetics Regulatory Report of Chile

Freyr provides Market Intelligence Reports which include a detailed study of market analysis, competitive intelligence, opportunity analysis, market potential that help you to understand the impact of Pharma market dynamics as per region specific HA’s across the globe. Check out more at the link –  Regulatory Market Intelligence Reports

Freyr provides Market Trend Analysis Reports which include information on qualitative analysis of on-going market trends, market forecasts and insights, go-to-market strategies and product launch for Cosmetic, Food Supplements, Health, Beauty, Skin & Personal Care Products as per region specific HA’s across the globe. Check out more at the link –  Pharma, Cosmetics & Food Supplements Market Trend Analysis Reports

Freyr  provides Regulatory Intelligence Reports which include information on global/regional Regulatory guidelines, dossier compilation, submission format changes, post-approval procedures for Cosmetics, food supplements, Traditional Medicines & Generic Products as per region specific HA’s across the globe. Check out more at the link –  Regulatory Intelligence Reports

Freyr  Reports provide Regulatory Intelligence, Market Intelligence & Trend Analysis Reports which include information on global/regional Regulatory guidelines, market trends, forecasts & insights, market analysis, competitive intelligence, opportunity, market potential as per region specific HA’s across the globe. Check out more at the link –  Freyr Reports

Freyr provides Pharma Regulatory Services in Ukraine for drug/biological products companies to support Product registration, Import license, dossier compilation & submissions in CTD format, Post approval changes, renewals as per Ukraine regulations under MOH. Check out more details at-  Pharma Regulatory Services in Ukraine

Freyr provides Pharma Regulatory Services in turkey for Medicinal products companies to assist with product development, market entry, dossier compilation & submissions in CTD format, Post approval changes, renewals as per the TMMDA regulations. Check out more details at –  Pharma Regulatory Services in Turkey

Freyr provides Pharma Regulatory Services in Egypt for medicinal products companies to support Drug registration, dossier submissions & compilation, eCTD conversion, Post approval changes, renewals as per EDA regulations. Check out more details at –  Pharma Regulatory Services in Egypt

Freyr provides Pharma Regulatory Services in Russia for Medicinal products companies to support in dossier submissions & compilation in CTD format, post approval change, HA query response & re-registrations, handling Normative Documents (ND) as per Roszdravnadzor under MOH. Check out more details at –  Pharma Regulatory Services in Russia

Freyr provides Pharma Regulatory Services in UK for Medicinal products companies to support in submissions & approvals of MAAs, Marketing Authorization Holder (MAH), local representative, gap analysis, dossier compilation, response to HA queries as per MHRA & EU Regulations. Check out more details at –  Pharma Regulatory Services in UK

Freyr provides Pharmaceuticals Regulatory Services to Sweden pharmaceutical companies to support in MAA Submission procedures (NP, MRP, DCP, CP), dossier compilation, Post-approval changes, MAH transfers, selection of the RMS & CMS as per EU & Sweden regulations. Check out more details at –  Pharma Regulatory Services in Sweden

Freyr provides Pharma Regulatory Services in Spain for drug/biological product companies to support MAA Submissions, change in Market Authorization Holder (MAH), selection of the RMS & CMS, QP, QPPV & Pharmacovigilance system master file (PSMF) as per AEMPS regulations. Check out more details at –  Pharma Regulatory Services in Spain

Freyr offers Pharma Regulatory Services in Poland for medicinal product manufacturers to support MAA submission, dossier compilation, legal representation services, selection of the RMS and CMS, Post-approval changes and lifecycle management as per EU & Poland regulations. Check out more details at –  Pharma Regulatory Services in Poland

Freyr offers Regulatory Services in Netherlands for pharmaceutical product manufacturers to support in APIs, ASMF/CEP, MAA submission, compiling dossiers, translation of documents such as SmPC, PIL and Post-approval changes as per EU & Netherlands regulations. Check out more details at –  Pharma Regulatory Services in Netherlands

Freyr offers Regulatory Services in Japan to global pharmaceutical companies which span across dossier preparation, drug approvals submissions, Good Quality Practice (GQP), QMS Application, SOP & Safety Reports Writing, Clinical Trial Notification (CTN) as per PMDA regulations. Check out more details at –  Pharma Regulatory Services in Japan

Freyr provides pharmaceutical regulatory services in Italy for drug & biological product companies which spans across ASMF/CEP, MAA submissions via various procedures (NP, MRP, DCP & CP), dossier preparation, Product life cycle management as per EU Regulations. Check out more details at –  Pharma Regulatory Services in Italy

Freyr provides Pharma Regulatory Services in Ireland for drug & biological products companies which spans across Regulatory support & strategy, Marketing Authorization Application (MAA), ASMF/CEP submissions, dossier compilation, lifecycle management as per EU/EEA Regulations. Check out more details at –  Pharma Regulatory Services in Ireland

Freyr provides Pharmaceutical Regulatory Services in Denmark to Medicinal Product companies which includes Product registration, MAA Submissions, lifecycle management, HA query response, variation submissions & license renewals as per EMA Regulations. Check out more at –  Pharma Regulatory Services in Denmark

Freyr provides Pharma Regulatory Services in Czech Republic to pharmaceutical manufacturers which spans across MAA Submissions, dossier submissions in eCTD format, QPPV, post-approval support, interaction with Health Authorities (HAs) as per EU Regulations. Check out more at –  Pharma Regulatory Services in Czech Republic

Freyr offers Regulatory services in China to drug manufacturers which span across Product registration, approvals, classification, local language translations, dossier submissions & compilation, Clinical Trial Application (CTA), CSR Writing as per CFDA regulations. Check out more at –  Pharma Regulatory Services in China

Freyr provides Pharma Regulatory Services in Belgium to Drug & biological products companies which includes MAA Submissions in eCTD format, selection of the RMS & CMS, ASMF/CEP, dossiers Submissions to HAs, post-approval support as per Federal Agency & EU regulations. Check out more details at –  Pharma Regulatory Services in Belgium

Freyr provides Pharma Regulatory services in Austria for pharma manufacturers which spans across strategic support on MAA procedures, pre-submission activities in eCTD format, dossier compilation, post-approval changes & lifecycle management as per EU/EEA regulations. Check out more details at –  Pharma Regulatory services in Austria

We help cosmetic companies with Cosmetic Classification, Registration in USA, Artwork Support, Ingredient & Label Assessment, Claims Review, Product Notification through Voluntary Cosmetics Registration Program (VCRP), PIF Compilation, Import Services as per US-FDA regulation and FD & C Act. Check out more at –  Cosmetic Classification, Registration in USA

We help cosmetic companies with Cosmetic Notification in South Africa, Formulation Review, Claims & Substantiation Services, Labeling Review, Product Information File (PIF) Compilation, Notification Holder, MOH Audit Consultancy, Renewals as per CFTA regulations. Check out more at –  Cosmetic Notification in South Africa

Freyr help cosmetic companies with Cosmetic Classification in Saudi Arabia, Formulation Review, Claims Review, Labeling Review, Translations, eCOSMA Registration/Notification, Legal Representative, Distributor & Import Services as per SFDA regulations. Check out more at –  Cosmetic Classification in Saudi Arabia

Freyr helps cosmetic companies with Cosmetic Registration in Russia, Formulation Review, Notification Holder, Claims & Substantiation Services, Labeling Review, Product Information File (PIF) Compilation, MOH Audit Consultancy, Renewals as per Rospotrebnadzor regulations. Check out more at –  Cosmetics Registration in russia

Freyr help cosmetic companies with Cosmetic Registration in Nigeria, Formulation Review, Notification Holder, Claims & Substantiation Services, Labeling Review, Product Information File (PIF) Compilation, MOH Audit Consultancy, Renewals as per NAFDAC regulations. To navigate manufacturers through compliant procedures, Freyr offers Cosmetics Regulatory support inclusive of legal representation, claims review and substantiation, labeling review, and other processes to ensure successful product notification / registration with the NAFDAC. Extending assistance in post-marketing phase, Freyr also helps in renewals of license in due periods. Check out more at –  Cosmetic Registration in Nigeria

Freyr helps cosmetic companies in Mexico with Cosmetic Classification, Registration in Mexico, Formulation Review, Claims & Substantiation Services, Labeling Review, Import license acquisition, Consulting & Renewal Services as per COFEPRIS regulations. With the recent change in the cosmetics regulations in cosmetics, it is no longer mandatory for cosmetic products to be sent to COFEPRIS for classification. As the registration process isn’t as stringent anymore so cosmetics can just be notified to COFEPRIS by including the product in the notice of operation and applying for the importation permit in order to import the product. Challenges concerning product classification and formulation review should also be addressed early on to ensure Regulatory compliance. Know more at –  Cosmetic Classification & Registration in mexico

We help cosmetic companies with Cosmetics Classification, Registration in Canada, Ingredient Analysis, Label Assessment, Claims Review & Consultation, Label Translation, Notification as per Health Canada (HC) under Food and Drugs Act and Cosmetic Regulations Act. Cosmetics market in Canada is flourishing with due credit given to teenagers and youth for top usage. In Canada, Cosmetics are regulated by Health Canada (HC) under Food and Drugs Act and Cosmetic Regulations Act. They are classified basing on the composition and proposed use of product. Hence identifying the right criteria is crucial for classification. It may also be noted that the skin sunscreen lotions, toothpastes, anti-dandruff shampoos and antiperspirants which exhibit the therapeutics effect are considered as drugs. As a well-explored and established market, entering Canadian Cosmetics market poses challenges not only in terms of competition, but also for its advanced regulations. Know more at –  Cosmetic...