The United States (US) is home to a vast array of food and dietary supplements, each claiming to offer a unique set of benefits for consumers. From vitamins and minerals to herbal supplements and protein powders, the market is flooded with products promising to improve health, manage health conditions, and reduce risks of diseases.
- May 14, 2024 Food and Food Supplements
- May 14, 2024 Publishing & Submissions, Regulatory Software & Services
Over the past few years there has been a gradual increase in medical devices and technologies, consisting of sensitive data of high monetary and intelligence value along with patient/institution information. To avoid loss and destruction of intellectual property, cybersecurity in the pharmaceutical industry is crucial and non-negotiable.
Cybersecurity threats faced by pharmaceutical companies:
- May 14, 2024 Food and Food Supplements
In today’s digital age, e-commerce platforms have become the go-to destination for purchasing a wide range of goods, including food products. However, ensuring the safety and accuracy of products that are sold online is paramount.
- May 14, 2024 Food and Food Supplements
When it comes to consumer safety and compliance with regulations, the European Union (EU) is known for having strict standards. Businesses wanting to sell their food and dietary supplements in the EU must follow these rules carefully.
- May 10, 2024 Pharmaceuticals, Regulatory Affairs
The Colombian healthcare system prioritizes patient safety and access to effective medications. To achieve these objectives, the National Institute of Drug and Food Surveillance (INVIMA) acts as the central Regulatory authority overseeing the approval process for pharmaceuticals.
- May 7, 2024 Pharmaceuticals, Publishing & Submissions
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
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.