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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 …

Actived: 2 days ago

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

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

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

Drug Master File (DMF) Submission

WebDuring DMF filing, the information on the Active Pharmaceutical Ingredients (APIs)/intermediates, packaging materials, excipients, and facilities can be submitted 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

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

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

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

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 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

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

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

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

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

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

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

Change Control Evaluation and Variation Submission Strategies

WebOverview Changes with the potential to impact Module 3 of the CTD require careful and thorough assessment to determine the appropriate course of action. The change control …

Category:  Course 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

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