Author: freyrsolutions

Effective Regulatory strategy planning is an important aspect of any discovery program. The planning and designing of a scientifically robust non-clinical development plan tailored to the specific requirements of the... Read More

Freyr is a leading Regulatory affairs services organization and has been a pioneer in offering strategic, multidisciplinary Regulatory affairs consulting services worldwide. Freyr provides comprehensive Regulatory affairs services throughout the... Read More

Toxicological Risk Assessment (TRA) is a comprehensive safety-evaluation report for a specific ingredient or contaminant in the product. TRA is a detailed scientific assessment report prepared by an expert toxicologist... Read More

Clinical trial monitoring ensures that the trial data is accurate, complete, and verifiable, as well as in agreement with the ethical and scientific norms. Robust clinical trial monitoring is vital... Read More

During drug development, companies may utilize a variety of clinical labelling-related tools that employ target labelling to facilitate drug development, while simultaneously aligning desired marketing and labelling objectives with the... Read More

NDS (New Drug Submission) is a process through which new drugs are approved and controlled by the Canadian Health Authority before entering the Canadian market. In Canada, new drugs are... Read More

The New Drug Application (NDA) is an application submitted to the US FDA for approval of a new drug through the 505(b)(1) NDA and 505(b)(2) NDA Regulatory pathway. Most sponsors... Read More

For conducting clinical trials with investigational drugs or drugs that are not approved for intended use, the sponsor must submit an Investigational New Drug Application (INDA) to the US FDA... Read More

To administer an Investigational Medicinal Product (IMP) on human population in the EU countries, the sponsors must submit a Clinical Trial Authorization (CTA) application and Investigational Medicinal Product Dossier (IMPD)... Read More

To obtain a clinical trial authorization, a Clinical Trial Application (CTA) must be submitted with all the required documentation as per the Health Authority (HA) requirements. Once submitted, the CTA... Read More