Regulatoryaffairs.freyrsolutions.com

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Health Authority interactions/Pre-submission meetings

WEBThis happens if the submitted data is insufficient or requires any further clarification on the quality, safety, and efficacy aspects. Health Authority interactions and pre-submission …

Actived: 8 days ago

URL: https://regulatoryaffairs.freyrsolutions.com/health-authority-interactions-pre-submission-meetings

Clinical Trial Application (CTA) Submissions

WEBA Clinical Trial Application (CTA) is a Regulatory dossier that is submitted to the Health Authority (HA) of the country in which a sponsor would like to conduct clinical trials with …

Category:  Health Go Health

Post Approval Change Submission, CMC Post Approval Changes

WEBPost-approval changes to drug substances. Post approval regulatory affairs and services are for maintaining compliance and ensuring the quality, safety, and efficacy of approved …

Category:  Health Go Health

Regulatory Affairs, Regulatory Needs, Benefits

WEBStrategic Regulatory Partnership. Eighty percent (80%) of Fryer’s customers are engaged in strategic, multi-year, Regulatory partnership with long term, guaranteed, cost and benefit …

Category:  Health Go Health

Abbreviated New Drug Submission (ANDS)

WEBRegistration of pharmaceutical products with Health Canada through the Abbreviated New Drug Submission (ANDS) application might have similar technical requirements to that …

Category:  Health Go Health

Pharmaceutical Regulatory Affairs Services

WEBPharmaceutical Regulatory Affairs services are important in the successful registration of medicinal products intended for human use with different Health Authorities (HAs). The …

Category:  Health Go Health

Regulatory Affairs Consulting, Regulatory Affairs Services, …

WEBFreyr provides comprehensive Regulatory affairs consulting services across the spectrum of global product development, registration, and commercialization. We offer informed …

Category:  Health Go Health

Investigational Medicinal Product Dossier (IMPD)

WEBIn order to administer the Investigational Medicinal Product (IMP) on human population in the EU countries, the Sponsors must submit a Clinical Trial Authorization (CTA) …

Category:  Health Go Health

NDS Health Canada, NDS application, SNDS Health …

WEBSupplement to a New Drug Submission (SNDS) is a supplement application submitted to Health Canada to notify changes that have substantial potential to have an adverse …

Category:  Health Go Health

Certification of Suitability (CEP) Submissions

WEBFiling Active Pharmaceutical Ingredient (API) information with the European Directorate (ED) for the Quality of Medicines and HealthCare (EDQM) is not mandatory. However, …

Category:  Medicine Go Health

Regulatory Strategy Consulting Services

WEBA well-defined Regulatory strategy consulting service supports Complete Response Letter (CRL) submission to Health Authorities (HAs) or response to HA queries. Strategic …

Category:  Health Go Health

Global Regulatory Intelligence Framework

WEBWith a comprehensive understanding of the industry, and having global presence across 120+ countries, Freyr helps organizations right from decoding Regulatory pathways to …

Category:  Health Go Health

Pharmaceutical Product Lifecycle Management

WEBA Marketing Authorization Holder (MAH) is responsible for keeping the registered dossier up to date as per country-specific requirements for pharmaceutical product lifecycle …

Category:  Health Go Health

Centralised Procedure

WEBCentralised Procedure. The Centralised Procedure (CP) is commonly used to obtain a marketing authorization for medicinal products. A CP is valid for all the …

Category:  Health Go Health

Drug Master File (DMF) Submissions

WEBDrug Master File (DMF) Submissions - Overview. Drug Master File Submission (DMF submission) is not mandatory for the US FDA, as DMFs are neither approved nor …

Category:  Health Go Health

Biologics Registration Services

WEBFreyr is a niche Regulatory service provider with significant experience in handling novel biologics, biosimilars, vaccines, blood & plasma products, and cellular & gene therapy …

Category:  Health Go Health

Biologics License Applications (BLA) Submissions

WEBThe Biologics License Application (BLA) serves as a gateway for the development and approval of biological medicinal products, which are promising in the prevention and …

Category:  Health Go Health

Abbreviated New Drug Application (ANDA) Submissions

WEBIn the realm of pharmaceuticals, an Abbreviated New Drug Application (ANDA) is the gateway for generic medicinal products to establish their therapeutic equivalence to …

Category:  Health Go Health

Active Substance Master File (ASMF) Submissions

WEBAn Active Substance Master File (ASMF), formerly known as European Drug Master File (EDMF) submission, is not a mandatory requirement for the European Union (EU) …

Category:  Health Go Health

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