Global Regulatory Affairs Services

Freyr provides comprehensive Regulatory services across the spectrum of global product development, registration and commercialization. We deliver informed advice and pragmatic services and solutions for new product and market authorizations, Health Authority submissions, post approvals, CMC and lifecycle management to help companies maximize their product’s commercial potential and market success.

Regulatory Affairs Services

Comments

Post a Comment

Popular posts from this blog

What is an FAP (Food Additive Petition) | FDA Approval Guide

 A Food Additive Petition (FAP) is a formal request sent to the U.S. Food and Drug Administration (FDA) asking for permission to use a new food additive that isn't Generally Recognized As Safe (GRAS). This process helps make sure any new substance added to food is checked for safety before it's used by consumers. FAPs are required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 409.What is included in a food additive petition?A standard Food Additive Petition sent to the FDA must include:Chemical Identity and Composition – A full description of the additive’s molecular structure and makeup.Manufacturing Process – A complete explanation of how the additive is made, to ensure it's consistent and pure.Proposed Uses and Levels of Use in Food – The specific foods the additive will be used in and the maximum amount allowed.Toxicological and Safety Data – Detailed safety evaluations, including toxicology reports and how much people might be exposed to.Environm...
Read more

Drug Registration Hong Kong: 10 Steps Regulatory Pathway

  Hong Kong’s pharmaceutical landscape is known for its rigorous and structured drug registration process, making it a vital checkpoint for global pharmaceutical companies targeting the Asia-Pacific market. The drug registration Hong Kong process is overseen by the Drug Office of the Department of Health, ensuring that only safe, effective, and high-quality medicinal products reach the public. Drug Registration Hong Kong Process: Complete Overview  To ensure a successful drug registration Hong Kong strategy, pharmaceutical sponsors must follow a sequence of regulatory steps—from submission through post-approval surveillance. Below is a detailed breakdown: 1. Submitting an Application Online  Companies must submit their applications via the  PHARMACEUTICALS REGISTRATION SYSTEM 2.0 (PRS 2.0)  in  Common Technical Document (CTD)  format. The application must include: Product details Manufacturing and GMP information Certificates of Pharmaceutical Product ...
Read more

How to Register Medicinal Products in New Zealand: Regulatory Requirements Explained

  New Zealand offers a transparent yet stringent Regulatory environment for therapeutic and medicinal products. Regulated under the Medicines Act 1981 and Medicines Regulations 1984, entry into the market requires careful navigation of Medsafe’s processes, technical documentation requirements, and pharmacovigilance expectations. This guide outlines the key steps, documentation formats, and submission pathways, for sponsors and Regulatory professionals targeting New Zealand. 1. Regulatory Oversight: Medsafe The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is the Regulatory agency responsible for evaluating the quality, safety, and efficacy of therapeutic products in New Zealand . Medsafe’s functions include: Review and approval of new medicines Regulation of changed and related products Market surveillance and pharmacovigilance Enforcement of labeling, advertising, and distribution standards 2. Product Classification Understanding product classification is es...
Read more