Cosmetic Regulatory Services
First-time-right Safety Assessment Services Across EU
Freyr provided first-time-right safety assessment services for shampoo and conditioners across EU for an established hair care provider
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Cosmetic Regulatory Services
End-to-end Toxicology Risk Assessment Services for Perfumes in European Economic Area
Freyr performed end-to-end gap analysis for specialized toxicology risk assessment for perfumes and body mists across EEA.
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Regulatory Operations
End-to-end Regulatory Support for Effective Regulatory Strategy and Timely 510(k) Submissions
Freyr supported an Indian mid-size medical device company for effective Regulatory strategy and in-time 510(k) Submissions with 100% quality for compliance
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Regulatory Operations
EMA Compliant Health Based Risk Assessment (PDE)
Freyr has performed toxicological gap analysis and streamlined 50 PDE value evaluations for established medicinal products
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Regulatory Operations
End-to-end Gap Analysis for IDMP Readiness across Europe
Freyr successfully identified and analyzed data sources to enable client conversant with IDMP requirements and ensured IDMP readiness for compliance across Europe region
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Regulatory Consulting
Successful Resource Deployment in Quick Turnaround Time
Freyr supported the client in completing their engagement by deploying additional resources and filled the gaps between various lifecycle processes.
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Regulatory Operations
End-to-end Gap Analysis and consultation for Marketing Authorization Submissions @ SFDA
Freyr has extended its region-specific and audit-ready dossier compilation services for Medical Devices / Health Products / OTC marketing authorization submissions @ SFDA.
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Regulatory Consulting
End-to-End TMF Gap Analysis, eTMF deployment and CAPA resolution
Freyr helps a global pharma company with end-to-end TMF gap analysis and eTMF deployment that ensured consistent and quality clinical trial processes.
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Regulatory Solutions
Successfully Built up Centralized eTMF System
Freyr successfully built up centralized eTMF tool based on client requirements and configuration that resulted in significant cost savings.
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Regulatory Operations
Successful DMF submissions within one week that yielded 70% cost benefits
Freyr successfully provided diverse set of submission & publishing services for the immediate objective of 1st eCTD DMF submission to Canada that increased cost benefits by 70% for the client.
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Regulatory Operations
Accelerated ASMF submissions in the EU within two weeks
Freyr achieved successful submission of ASMF in eCTD in the EU within two weeks that not only resulted in 70% cost benefits but also accelerated ahead of competition.
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Regulatory Medical Writing
High Quality, Error Free Documents for Global Top 20, Pharma Company
Freyr helps a global client with fast-track Preparation of Protocols, Protocol Amendments, IBs, and CSRs in stringent timelines providing significant cost benefits.
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Regulatory Operations
Successful HA Renewal of 14 Products with Quick Turnarounds in Strict Timelines
Freyr provided regulatory support to ensure renewal of 14 OTC products of the client registered in Ukraine ensuring uninterrupted product supply.
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UDI Submissions
First-Time-Right Solution For 99.7% Tasks for UDI Submission
Freyr implements “Freyr IDENTITY” tool to streamline all the GUDID attributes for UDI Submissions.
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Regulatory Operations
Saved 80% Time Effort on Master Dossier Creation for 12 Countries
Freyr harmonized master dossier approach and reduced the time effort by 80% saving 40% on Cost of Compliance.