Freyr Solutions

  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...

  When pharmaceutical or biotech companies submit a New Drug Application (NDA), Biologics License Application (BLA), or Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA), they often hope for an approval letter. However, in many cases, the outcome is a Complete Response Letter (CRL) — a detailed notice from the FDA that outlines why the application cannot be approved in its current form. Receiving a CRL can be disheartening, but it isn’t a dead-end — it’s a critical checkpoint. For Regulatory teams and sponsors, a CRL presents a unique opportunity to refine, reassess, and reinforce the submission strategy. So, how do you master the art of responding to an FDA CRL and get your submission back on the path to approval? Understanding the Anatomy of a CRL A Complete Response Letter is the FDA’s formal mechanism to communicate deficiencies found during the review of a submitted application. These can range from clinical data gaps, manufacturing concern...

  In the complex and highly regulated pharmaceutical industry, ensuring consistent and compliant labeling across global markets is not just a Regulatory requirement—it's a critical part of product integrity and patient safety. As companies expand into new regions, the challenge of maintaining alignment between the   Company Core Data Sheet (CCDS)   and   Local Product Documents (LPDs)   becomes increasingly complex. Effective   global labeling governance   is essential to streamline this alignment, avoid discrepancies, and uphold   Regulatory compliance   across jurisdictions. Understanding CCDS and LPD The  Company Core Data Sheet (CCDS)  is a global reference labeling document created by a pharmaceutical company. It outlines the company’s position on product safety, efficacy, indications, contraindications, dosing, and pharmacovigilance data, all in alignment with the approved clinical data. On the other hand, the  Local Prod...

  In today’s dynamic pharmaceutical landscape, labeling has evolved beyond being a static Regulatory artifact. As life sciences companies grapple with the twin challenges of global compliance and patient-centricity,   digital labeling solutions   are emerging as a pivotal enabler of transformation. Gone are the days when Regulatory labels were limited to unchangeable   PDFs . The industry is moving toward   interactive labels   using Structured Product Labeling (SPL) frameworks and smart content management systems. The Limitations of Traditional Labeling Traditionally, pharmaceutical labeling relied heavily on static formats, such as PDFs, that provided little room for interactivity, dynamic updates, or multi-channel dissemination. These formats were suitable for printing and submission but fell short in the digital age, where  real-time updates , patient accessibility, and  global label harmonization  are key. Static labels often result in: ...