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Regulatory Services for Generic Drugs, Generic Drug Approval …

WebIntroduction to Generics. Global Regulatory services for generic drug products have evolved over the past few decades. Owing to increasing demand for these products, given the …

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URL: https://genericspharma.freyrsolutions.com/

Health Canada Drug Master File (DMF) Submission

WebThe Health Canada Drug Master File (DMF) is a document submitted to Health Canada to provide important information about an Active Pharmaceutical Ingredient (API), finished …

Category: Health Go Health

Publishing and Submission Freyr Generics

WebFreyr Expertise. 01. End-to-end generic medicine application Regulatory submission and publishing including submission level and document level publishing activities. 02. …

Category: Medicine Go Health

Health Canada ANDS

WebHealth Canada ANDS - Overview. Abbreviated New Drug Submission (ANDS) is the application submitted to Health Canada for the review and approval of generic drugs …

Category: Health Go Health

Regulatory Strategic Guidance

WebHealth Canada’s Regulatory strategic guidance involves setting up the right Regulatory roadmap during product development and studies to be performed specific to the dosage …

Category: Health Go Health

Active Substance Master Files, Submission of ASMF/CEP

WebThe EMA guideline on the Active Substance Master File procedure must be followed to submit ASMFs in compliance with Health Authority (HA) requirements. The submissions …

Category: Health Go Health

Competitive Generic Therapies Designation

WebCompetitive Generic Therapies (CGTs) are designations for products that have inadequate generic competition in the market due to low market potential, less profit margin, or …

Category: Health Go Health

Publishing and Submission Freyr Generics

Web01. Support for end-to-end generic medicine applications Regulatory submission and publishing including submission level and document level publishing activities. 02. …

Category: Medicine Go Health

Hybrid Applications Freyr Generics

WebIn such scenario, bridging studies are critical to show the equivalency with the reference medicinal product for on-time registration and receipt of approval for hybrid application …

Category: Health Go Health

Canada Health Authority Interactions

WebCanada Health Authority Interactions - Overview. Regulatory agency interactions are key in achieving a positive impact on the approval timelines and overall costs. Since the final …

Category: Health Go Health

Post-approval Changes to Drug Substance

WebOffering support in post-approval changes to generic drug substances. Freyr offers the following services to medicinal product manufacturers: 01. Change control support and …

Category: Health Go Health

Change Control Evaluation and Submission Strategy

Web01. Evaluation of change control and supporting documents in line with HC post-approval submission guidelines. 02. Preparation of a post-approval submission strategy for the …

Category: Health Go Health

Introduction to Generics Freyr Generics

WebIntroduction to Generics. Generic medicines had major milestones including, Regulatory laws to support generic development, which encouraged manufacturers to explore the …

Category: Medicine Go Health

Health Canada Query Management Freyr Generics

WebFreyr Expertise. 01. Thorough review of the deficiencies received from HC against registered content. 02. Preparation of an action plan. 03. Preparation of response …

Category: Health Go Health

US FDA Health Authority Interactions

WebUS FDA Health Authority Interactions - Overview. Drug product manufacturers/ANDA holders should utilize the provisions in the US FDA for Health Authority interactions to …

Category: Health Go Health

Due Diligence Assessment of ANDA

WebDue diligence assessment involves a detailed review of the existing data, Regulatory strategy, and study plans for the generic drug product per the Health Authority (HA) …

Category: Health Go Health

Abbreviated New Drug Application

WebAbbreviated New Drug Application - Overview. The Abbreviated New Drug Application (ANDA) is an application submitted to the United States Food and Drug Administration …

Category: Food Go Health

Marketing Authorization Procedure in Europe, MAA Registration

WebThis authorization enables Marketing Authorization Holders (MAHs) access to all EU member states for manufacturing and distributing their products. The marketing …

Category: Health Go Health

Health Authority Interactions in Europe

Web08. Support in case of application rejection by Regulatory authorities. 09. Requesting scientific advice from the Regulatory authority before/during the submission. 10. …

Category: Health Go Health

ANDA Post-approval Changes, US FDA Post-approval Changes

WebThese post-approval changes are submitted to the US FDA by filing supplements or amendments per Section 506A of the Federal Food, Drug, and Cosmetic Act and § …

Category: Supplements, Food Go Health

Pre-ANDA Submission, ANDA Submissions, Pre-ANDA Meeting

WebPre-ANDA Submissions - Freyr Expertise. Submit a pre-ANDA meeting request to the USFDA. Preparation of a suitable Regulatory strategy (product development, pre …

Category: Health Go Health

ANDA Post-approval Change Submissions

WebANDA post-approval changes must be submitted to Health Canada (HC) as a supplement/amendment/annual report based on the complexity and impact on the quality …

Category: Health Go Health

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