Genericspharma.freyrsolutions.com

Regulatory Services for Generic Drugs, Generic Drug Approval …

WebFreyr provides Regulatory solutions and services to large, mid & small global life sciences companies. Our highly-skilled Regulatory experts understand customer requirements …

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

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

US FDA Health Authority Interactions

WebIn case of Competitive Generics Therapies (CGT) requests, the US FDA agent interactions will be allowed for pre-development, FDA pre-submission meetings, and mid review …

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

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

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

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

Sunset Clause for Marketing Authorizations, Sunset Clause

WebThe sunset clause was introduced by the European Medicines Agency (EMA) per Regulation (EC) No. 726/2004, Article 14 (4-6), to monitor the marketing status of …

Category: Medicine Go Health

Regulatory Strategic Guidance

Web01. Planned submission of generic drug applications as per Canada’s drug registration guidelines. 02. Evaluate the latest Health Canada’s Regulatory strategic guidance and …

Category: Health Go Health

Generics Medicine Regulatory Services Provider, Contact Freyr

WebUnited States of America. 150 College Road West, Ste 102, Princeton NJ - 08540, USA. Fax: +1 866 486 6883 Phone: +1 908 483 7958 / +1 908 409 5626

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. …

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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 …

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Health Canada ANDS

WebAbbreviated New Drug Submission (ANDS) is the application submitted to Health Canada for the review and approval of generic drugs against the Canadian Reference Product …

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

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

Canada Health Authority Interactions

WebRegulatory agency interactions are key in achieving a positive impact on the approval timelines and overall costs. Since the final decision on drug product approvals lies with …

Category: Health Go Health

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

WebPre-ANDA submission is a formal written request for feedback from the US FDA to assist applicants with generics application preparation. Before submitting a generic application …

Category: Health Go Health

US FDA Query Management (IRs/DRLs/CRLs) Freyr Generics

Web01. Thorough review of the deficiencies received from the USFDA against registered content. 02. Preparation of an action plan. 03. Preparation of response strategy and …

Category: Health Go Health