The regulatory landscape is changing. It is no longer just a static document describing what compliance is. Today, with an ever-increasing demand for regulators, vast amounts of data are to be collected and analyzed to ensure compliance. This sets up a unique problem: handling this "big data" effectively while maintaining robust regulatory document management.
- May 17, 2024 Regulatory Intelligence, Regulatory Software & Services
- May 15, 2024 Pharmacovigilance, Pharmaceuticals, Regulatory Medical Writing
The world of pharmaceuticals is ever evolving, with new drugs/devices/cosmetics being introduced to the market regularly. While clinical trials provide initial safety and efficacy data, the true test of a pharmaceutical product’s impact (both positive and negative) comes when it is used widely by a diverse population, i.e., in the post-marketing setting. This is where pharmacovigilance (PV) systems play a critical role.
- May 15, 2024 Pharmacovigilance, Pharmaceuticals, Regulatory Medical Writing
In the critical arena of pharmacovigilance, where even minor inconsistencies can have life-altering consequences, standardized terminologies are the bedrock of drug safety.
- May 15, 2024 Pharmaceuticals, Compliance, Audit and Validation
The pharmaceutical industry is a critical component of the global healthcare system, providing life-saving medications to millions of people. However, the complexity of pharmaceutical supply chains can lead to challenges in ensuring the quality, safety, and availability of medicines. To address these challenges, the industry must focus on driving compliance and transparency throughout the supply chain.
- May 15, 2024 Pharmaceuticals, Compliance, Audit and Validation
Maintaining stringent contamination control measures is paramount to ensuring product safety, efficacy, and regulatory compliance. Contamination can jeopardize the quality of pharmaceutical products, compromise patient safety, and result in costly recalls. Therefore, implementing robust strategies for contamination control is imperative.
- May 14, 2024 Food and Food Supplements
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 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.