The global pharmaceutical market is expected to reach a staggering $1.5 trillion by 2025, fuelled by continuous innovation and a growing demand for life-saving treatments. The electronic Common Technical Document (eCTD) submission process plays a pivotal role in achieving this goal.
- May 7, 2024 Pharmaceuticals, Publishing & Submissions
- May 7, 2024 Pharmaceuticals, Publishing & Submissions
Regulatory submissions are essential in the pharmaceutical and biotech sectors as they play a key role in introducing new therapies to the market and maintaining compliance. Companies in the United States (US) and the European Union (EU) must have a thorough understanding of the different types of submissions mandated by Regulatory authorities. These submissions, ranging from clinical trial applications to post-…
- May 6, 2024 Pharmaceuticals, Regulatory Artwork Services
Even after a successful Regulatory nod, the journey for a medical product isn't over. Post-market surveillance (PMS) and enforcement become crucial aspects of ensuring patient safety and product efficacy. Regulatory artwork, which played a key role in your initial application, remains relevant in this phase as well.
- May 6, 2024 Pharmaceuticals, Regulatory Artwork Services
The pharmaceutical industry is a realm where precision and accuracy are not just desired but mandated. Every aspect of pharmaceutical production, from drug formulation to packaging, is governed by stringent regulations to ensure patient safety and product efficacy. Among these critical elements is the creation of artwork for pharmaceutical products, which encompasses everything from labeling to package inserts.
- May 6, 2024 Pharmaceuticals, Regulatory Labeling
In today's globalized world, the need for accurate and efficient label translation is more critical than ever, especially in the highly regulated pharmaceutical industry. The translation management process is a complex series of steps that ensures that documents, product information, and clinical trial data are accurately translated and meet the Regulatory requirements of different countries.
- May 6, 2024 Pharmaceuticals, Regulatory Labeling
In the world of regulatory compliance and quality control, the implementation, review, and validation of data sheets are critical processes that ensure the integrity and reliability of data. These steps are essential for making informed regulatory decisions, maintaining product quality, and ensuring public safety.
- May 2, 2024 Medical Devices
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is the central Regulatory authority that oversees medical device regulations in New Zealand.
- May 2, 2024 Medical Devices
The medical device Regulatory framework in New Zealand is built to ensure that medical devices sold in the country are safe and fit for their intended purposes. The Medicines Act, 1981 and its revisions, the Medicines Regulations, 1984, and the Medicines (Database of Medical Devices) Regulations, 2003 govern New Zealand’s medical device Regulatory system.
- April 30, 2024 Publishing & Submissions, Regulatory Software & Services
Governance on paper is designed around time and is continually evolving. New laws are born, standards evolve, and aligning with the ever-changing landscape gives the feeling of not catching up. However, an opposite situation is possible – foreseeing these changes; acting rather than waiting for the same to unfold; making you one step ahead of all your competitors.
- April 30, 2024 Pharmacovigilance, Regulatory Medical Writing
The world of medicine relies on a delicate balance between the effectiveness of drugs and their safety for patients. Pharmacovigilance, the science of monitoring drug safety, plays a crucial role in this equation. At the heart of pharmacovigilance lie the databases that store and analyze vital information on adverse drug reactions (ADRs).