Freyr Solutions

  Navigating the complexities of regulatory publishing requires a delicate balance between speed and compliance. In the pharmaceutical and biotech industries, getting essential documents to regulatory authorities quickly and accurately is paramount. Here's how organizations can maximize both speed and compliance in their end-to-end regulatory publishing processes: Streamlining the Publishing Workflow Centralized Document Management Systems:  Implementing a robust, centralized document management system (DMS) is the foundation for efficient regulatory publishing. A DMS ensures all documents are stored securely, easily accessible, and maintains version control. This eliminates time wasted searching for the correct document and reduces the risk of using outdated versions. Standardized Templates and Processes:  Establishing standardized templates for common regulatory submissions (e.g., eCTD, NeeS) and clearly defined publishing processes can significantly accelerate turnarou...

When you start selling cosmetics in Nigeria, you’ll come across the term NAFDAC. NAFDAC stands for the National Agency for Food and Drug Administration and Control. It is the government body responsible for making sure that food, drugs, cosmetics, medical devices, chemicals, and packaged water are safe, of good quality, and properly labeled.For companies that make, import, or sell cosmetics in Nigeria, it’s very important to understand what NAFDAC does. This helps them follow the rules and successfully enter the market.What Does NAFDAC Do for Cosmetics?NAFDAC is in charge of regulating, registering, and checking all cosmetics sold in Nigeria. Its main goals are:To make sure cosmetics are safe: They shouldn’t have harmful ingredients or cause health problems when used normally.To check the quality: Products should meet high standards and not be fake or poor quality.To ensure proper labeling: Labels must have correct information like ingredients, directions for use, warnings, batch numbe...

Australia's cosmetics market is growing quickly around the world because more people are looking for new and good-quality products. But to enter and compete in this market, brands need to understand Australia's special rules. In Australia, most cosmetics are treated like industrial chemicals, not like medicines.For brands, following the rules isn't just about staying legal—it's also important for building trust with customers and keeping the brand's name safe.Different government groups are in charge of regulating cosmetics in Australia , depending on what the product does and what it says:- **Australian Industrial Chemicals Introduction Scheme (AICIS):**    This is the main group that oversees cosmetics. Any business that brings in or makes cosmetics must sign up with AICIS. They need to make sure all ingredients are allowed and follow the rules. Each year, they also have to report on the chemicals they use.- **Therapeutic Goods Administration (TGA):**    If a prod...

  Introduction New Zealand is transitioning to the  Therapeutic Products Act (TPA) , replacing the Medicines Act 1981. This shift marks the beginning of a New Zealand risk-based Regulatory framework that consolidates oversight for medicines, biologics, sterile products, medical devices, and natural health products under a unified system. For sponsors and manufacturers, aligning with the  Medsafe New Zealand regulatory guidelines  for medicines is no longer optional—TPA implementation in New Zealand 2026 demands proactive compliance to avoid market disruption. It also brings increased focus on Pharmacovigilance in New Zealand to ensure continuous safety throughout a product’s lifecycle. Core Regulatory Shifts 1. Expanded Scope & Licensing The new law introduces regulatory oversight of novel therapies like gene and cell therapies, combination products, and advanced biologics. This expansion requires adapting to new licensing frameworks and submission types as part ...

  In today’s evolving Regulatory landscape, pharmaceutical companies are expected to not only bring high-quality products to market but also maintain that quality consistently throughout the product lifecycle. While Quality by Design (QbD) is widely recognized during product development and Regulatory submission stages, its real power unfolds in the post-approval phase — where operational excellence, Regulatory agility, and global market expansion intersect. This blog explores the critical role of QbD in the post-approval stage, the Regulatory expectations, and how life sciences companies can leverage it for compliant and efficient lifecycle management. A Quick Refresher: What is Quality by Design? Quality by Design (QbD) is a systematic, science-based, risk-managed approach to pharmaceutical development. Endorsed by ICH guidelines (especially ICH Q8, Q9, Q10), it focuses on: Defining a Quality Target Product Profile (QTPP) Identifying Critical Quality Attributes (CQAs) Determining...

  South Korea has put in place a strong set of rules for regulating chemicals and household products to keep people healthy, workers safe, and the environment protected. Any company that wants to make, bring into the country, or sell chemical products in South Korea must follow these rules. These rules are mainly managed by the Ministry of Environment in South Korea. Let's look at the main chemical regulations and what is needed to register a chemical product in South Korea. Key Regulations   Two major laws help ensure chemical safety in South Korea: Consumer Chemical Products and Biocides Safety Act (K-BPR) – This law controls the approval and use of products that kill pests or microorganisms. It makes sure these products are safe for people and the environment by requiring strict checks and approvals. Act on Registration, Evaluation, etc. , of Chemicals (K-REACH) – K-REACH requires companies to register, evaluate, and manage chemical substances made or imported into So...