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A Periodic Adverse Drug Experience Report (PADER) is a type of aggregate safety report and is a requirement of the US FDA for all pharmaceutical products marketed in the USA. Meticulous analysis and evaluation of cumulative safety information help build a product’s safety profile, which is necessary for evaluating the benefit-risk ratio for a product.
Pharmacovigilance signal management processes are necessary for the early detection of unknown adverse events of medicines, identifying early warnings of adverse events (serious & non-serious), determining new risks and existing benefit-risk balance of medicinal products, and determining what regulatory actions to take to minimize patient risk. Here is a complete guide on pharmacovigilance signal management by DDReg.
A pharmacovigilance system master file (PSMF) is a safety requirement for pharmaceutical products distributed in Singapore. This can be problematic for MAHs that require a basic PV system, causing the products to be rejected by the market. At DDReg Pharma, our pharmacovigilance services in Singapore include setting up a comprehensive and compliant pharmacovigilance system. Visit us to get a quote.
To meet regulatory requirements and ensure patient safety, companies must stay current with technological and regulatory developments by carefully selecting the best tools and suppliers to meet their internal needs. However, this process poses significant challenges in ICSR processing.
Learn about the key components of a risk management plan for pharmacovigilance, including risk assessment, mitigation, and monitoring.
Pharmacovigilance is essential to ensuring patient safety in biosimilars and generics. Learn about the critical differences between pharmacovigilance for biosimilars and generics with this informative blog post. Get a better understanding of why these safety measures are crucial for patient care and how they shape the pharmaceutical industry today.
Pharmacovigilance is crucial to drug safety and regulatory compliance in the pharmaceutical industry. This blog post provides a comprehensive overview of pharmacovigilance in Japan, the USA, and Europe. The post covers the regulatory frameworks of these regions and how they differ, as well as the key principles and guidelines that govern pharmacovigilance practices.
ICSR stands for Individual Case Safety Report, which is a document that contains information about adverse events or side effects associated with the use of a particular drug or medical product. In this blog post, we discuss the importance of ICSRs in pharmacovigilance, how they are generated, and their significance in ensuring the safety and efficacy of drugs and medical devices.
An ICSR, or individual case safety report, is a key component of pharmacovigilance, monitoring and evaluating medicines' safety and efficacy. An ICSR is a report describing an adverse event or side effect a patient has experienced after taking a medication. To learn more about ICSR, read our latest blog.
In the pharmaceutical industry, data integrity is essential to ensure the safety and efficacy of products. The blog discusses the crucial role of data integrity in risk management in the pharmaceutical industry. It highlights the impact of maintaining accurate and complete data to ensure the safety and efficacy of pharmaceutical products.
Understanding the USFDA safety requirements for pharmacovigilance is crucial for pharmaceutical companies. At DDReg Pharma, we have created a comprehensive guide to help you navigate these complex regulations. From adverse event reporting to risk management plans, our blog covers everything you need to know to ensure compliance and patient safety. Read our blog to learn more.
The Purple Book lists biological products, while the Orange Book lists drugs approved under the Federal Food, Drug, and Cosmetic Act. These books are important tools for healthcare professionals, as they provide information on drug safety and effectiveness and assist with approving new products. Read our blog post to learn more about Purple Book and Orange Book.
Traditional manual submission methods can be time-consuming and prone to errors, but with the help of AI technology, the submission process can become faster and more accurate. Our blog discusses the benefits of using AI-powered automation tools for streamlining Individual Case Safety Report (ICSR) submissions. Read more to learn more.
DDReg Pharma provides regulatory-compliant pharmacovigilance services to pharmaceutical companies in the USA. Contact us for more information.
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We are a team of experienced Regulatory Affairs Services providers in USA and India.DDregpharma provides professional regulatory services for products.
DDReg offers Pharmacovigilance Services in the UK are in accordance with the guidelines established by the Medicines drug saftey and Healthcare products Regulatory Agency (MHRA).
DDReg provides regulatory services in UK. We deliver reliable safety measures with experts to facilitate effortless delivery of product launches market authorizations, and regulatory filings.
As part of our drug safety portfolio and Pharmacovigilance Services in Indonesia we help develop and deliver customized risk management strategies and tailored procedures that classify safety risks.
DDReg Provides Pharma Regulatory Services in Germany, we fulfill license management services in Germany as per BfArM guidelines. provides Strategies, Due Diligence, CMC Advisory and life Cycle Management services.
DDReg provides pharmacovigilance Services and Drug Safety Solutions in Germany, according to the Federal Institute (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).