freyr Profile

freyr

Join Date:
2015-03-24

Blogs Owned

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 .

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Other Tags: Cosmetic Classification, Cosmetic Notification, Health Canada

We helps cosmetic companies in Mexico with Cosmetic Classification, Registration in Mexico,.. Formulation Review, Claims & Substantiation Services, Labeling Review, Consulting & Renewal.. Services as per COFEPRIS regulations

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Other Tags: Cosmetic Classification, Cosmetic Registration

We 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.

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Other Tags: Cosmetic Notification,

Freyr IDENTITY, an UDI compliance solution for medical device manufacturers to meet the FDA mandated.. UDI compliance for their Class I, II and III devices.

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To understand the global outlook of biosimilars in terms of market and Regulatory perspectives, let.. us look at the market and Regulatory scenarios of biosimilars in two of the world’s biggest.. markets, the United States of America (USA) and Europe.

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Other Tags: Regulatory Market For Biosimilars, Regulatory Market For biological pr, Regulatory Market For Europe and US, Regulatory Market For Europe, Regulatory Market For US FDA

This article talks about the medical device registrations with FDA in USA and the regular submission.. pathways which include De Novo, Humanitarian Device Exemption

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Other Tags: Medical Devices, Registration Pathway, Medical Device Registration, Regulatory Strategy, 510(k)

Freyr IDMP Software supports life cycle management of IDMP data, tracks changes and generates.. EVMPD/IDMP compliant XML files until ISO IDMP Standards

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We help cosmetic companies with Cosmetic Classification, Registration in USA, Artwork Support,.. Ingredient & Label Assessment, Claims Review, Product Notification through Voluntary Cosmetics,.. PIF Compilation, Import Services as per US-FDA.

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Other Tags: Cosmetic Classification, Cosmetic Registrations, FDA, VCRP

Freyr supports to prepare elemental impurities risk assessment reports throughout the ICH region as.. per ICH Q3D, which involves with pre-assessment & final-assessment.

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

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Other Tags: MAA Submission Austria, NCE, MAH

Freyr’s Regulatory Intelligence Portal gathers publicly available regulatory information, which.. includes worldwide reach of regulations, pharmaceutical updates using a system called Freyr INSIGHTS

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Freyr provides Pharma Regulatory Services in Belgium to Drug & biological products companies.. which includes MAA Submissions in eCTD format, ASMF/CEP, dossiers Submissions to HAs, post-approval.. support as per Federal Agency & EU regulations.

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Other Tags: APIs, ASMF/CEP, MAA Submissions Belgium

Freyr offers Regulatory services in China to drug manufacturers which span across Drug registration,.. approvals, classification, local language translations, dossier submissions & compilation,.. CTA, CSR Writing as per CFDA regulations.

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Other Tags: CFDA registration China

Freyr Label, Labeling and Artwork Management software which provides dynamic overview of Company.. Core data sheet (CCDS), has the ability to store and archive labelling info and supporting.. documents.

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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 HAs as per EU Regulations.

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Other Tags: Medicinal Products Czech Republic, MAA Submissions Czech Republic

As the FDA’s UDI initiative relies heavily on the quality data to be submitted to the GUDID.. database, companies must keep a close eye on common errors that go

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17 - freyr

Freyr eTMF Solution provides business process and technology solutions that enable life science.. organizations to manage their Trial Master File (TMF) operational and compliance needs. eTMF.. Management services, eTMF Solutions provider

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Freyr offers Consulting, Software & Operations Outsourcing Services of Regulatory Affairs,.. Operations & Information Management functions to Large & Small-Medium Life Sciences.. companies.

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Other Tags: Software ,Technology

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 Regulation

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Other Tags: MAA Submissions Denmark, Regulatory Support Denmark

Freyr provides Pharma Regulatory Services in Ireland for drug & biological products companies.. which spans across Regulatory support & strategy, MAA, ASMF/CEP submissions, dossier.. compilation, lifecycle management as per EU/EEA Regulations.

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Other Tags: APIs Ireland, ASFM/CEP Ireland, MAA Submissions Ireland

https://www.freyrsolutions.com/blog/regulations-for-children-cosmetics-by-anvisa

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Other Tags: Children Cosmetics, Children Cosmetics, registration exemption, Brazil cosmetics, Cosmetic registrations

Be it a drug, device, cosmetic or food product, it is essential to convey the product information.. with respect to its usage, indications, warnings and other crucial aspects that are informative and.. beneficial to the end-user

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Other Tags: labeling, Digital Labeling, Packaging, Regulatory, Life Sciences

Is it that important to ensure the compliance and safety of the Cosmetic products from the.. consumer’s perspective? Considering the recent adverse events

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Other Tags: cosmetic compliance, cosmetics regulatory, registration procedures, geo-specific cosmetics regulatory

Freyr provides pharmaceutical regulatory services in Italy for drug & biological product.. companies which spans across ASMF/CEP, MAA submissions via various procedures , dossier.. preparation, Product life cycle management as per EU Regulations.

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Other Tags: MAA Submission Italy, Dossier Preparation Italy

Freyr SUBMIT is a web based, cloud hosted eCTD publishing Software for regulatory document.. Management for electronic submissions by pharma companies to comply with FDA, EMA, Health Canada etc

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Freyr Artwork Pack Management CoE provides innovative, cost-effective, and creative graphic design.. & artwork services to support new product launches and brand re-designs for global lifesciences.. companies.

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Other Tags: Cosmetic artworks

Finished drug products contain minute amount of impurities which find their way into drugs at.. various junctures of manufacturing.

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28 - PLM tool

Freyr team has exposure to Pharmaceutical Artwork Product lifecycle management/PLM tools which spans.. across Centralization of end-to-end artwork process, Audit-trail management, 21CFR compliant, GMP.. compliant, Safety label changes.

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Other Tags: Cosmetic artworks, artwork lifecycle management tools

International Organization for Standardization (ISO) has recently updated the ISO/TS 19844,.. “Implementation guidelines for ISO 11238 for data elements and structures for the unique.. identification and exchange of regulated information on substances”.

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Other Tags: IDMP Implementation Guidelines, ISO 11238, ISO/TS 19844

Freyr helps API Manufacturers in CEP compilation, review & submission to EDQM for all types of.. APIs as per EDQM guidelines for approval of MAAs/ANDS.

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Other Tags: CEP Application, Certification of S

The latest mandates of CFDA on new Medical Device Classification Catalog and expected to affect the.. medical devices registration process for new applicants and existing manufacturers in case of.. renewals, and re-classifications in china.

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Other Tags: New Medical Device Classification

Freyr rDMS is an electronic Regulatory Document Management system/software helps life sciences.. companies to manage regulatory data and documents in efficient manner.

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We offer Clinical Trial Auditing & Monitoring services for both the clinical and bio-analytical.. phases of the Bioequivalence (BE) studies & Bioavailability (BA) studies, Clinical SOP.. preparation & review as per ICH GMP, US FDA, EMEA, ANVISA re

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Other Tags: Clinical Trial Audit, Monitoring, Bioequivalence, Bioavailability studies, Bioequivalence (BE) study services

We offer clinical protocol preparation and review services, Clinical Trial Audit & Monitoring.. Services for clinical & bio-analytical phases as per the specific standard like ICH GCP, USFDA,.. EMEA, ANVISA regulations.

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Other Tags: Clinical Trial Audit & Monitoring S, ICH GCP, USFDA

Freyr helps cosmetic companies with Cosmetics Classification, Notification/Registration in.. Australia, Ingredient Analysis, Label assessment, Claims Review & Consultation as per TGA.. regulation for cosmetic products under the NICNAS & ICNA Act.

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Other Tags: Cosmetic Classification, Cosmetic Registration

Freyr tailors solutions to meet a variety of medical writing needs with respect to clinical trial.. services starting from strategic services for the conduct of clinical trials till the submission of.. clinical trial dossier, compilation and review.

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Other Tags: Clinical study report writing, Clinical trial dossier, Clinical sections ANDAs, Clinical sections NDAs, IND application supporting document

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