Adverse event processing & causality assessment is the preferred way to identify a drug product related risk and its association with patient safety. An Individual Case Safety Reports (ICSRs) is an important source of information that contains crucial data on an adverse event that a patient is experiencing when taking a drug. The purpose of […]
ICSR PROCESSING & PATIENT SAFETY Read More »
An important aspect of patient safety is Pharmacovigilance, that is the science and activities relating to the Detection, Assessment, Understanding, and Prevention of adverse effects or any other medicine-related problems. As an end-to-end pharmacovigilance service provider, DDReg is a key stakeholder in the drug safety spectrum and is committed to ensure utmost patient safety. Our
Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety Read More »
Florence Nightingale once said “The very first requirement in a hospital is that it should do the sick no harm” 1 This notion has been evolving ever since to provide utmost patient safety in the healthcare processes. Studies have emphasized that medication errors are one of the principal causes of adverse events in patients constituting
Medication errors: Self-medication Read More »
The European Union (EU) implemented significant changes in the way clinical trials (CTs) are conducted where the EU Clinical Trial Regulation (EU CTR) (Regulation EU 536/2014) came into effect early this year, on 31st January 2022. The aim of the new regulation was to harmonize how clinical trials are supervised and assessed by enhancing collaboration
Understanding the EU Clinical Trial Information System Read More »
Treating Clostridium difficile infections using biotherapeutics Biotherapeutics are therapies that are essentially based on isolating large molecules of proteins, produced by live organisms, engineered to prevent, treat, and cure various disease conditions, instead of chemically synthesizing drugs in the laboratory. Patients across the globe have benefitted from the use of biotherapeutics to treat various disease
Treating Clostridium difficile infections using biotherapeutics Read More »
Single bookmarking and hyperlinking tasks were conducted manually by regulatory publishing team members at DDReg which was a repetitive and time-consuming task. The key objective was to implement tools that would automate repetitive tasks to create a more efficient workflow for filing and e-functionality within the organization The regulatory publishing team at DDReg conducted deep
Incorporating plug in tools to facilitate regulatory publishing tasks Read More »
A U.S.-based manufacturer had deficiencies in their abbreviated new drug application (ANDA) as it caused the U.S. FDA to Refuse to Receive (RTR) the ANDA. If additional material was submitted to correct the deficiencies, then the amended ANDA is considered a new ANDA submission and is subjected to pay a new ANDA fee. The manufacturer
Legibility checks to avoid ANDA rejection Read More »
One of the top three biopharmaceutical companies approached DDReg to get the dossiers for their product submitted to the Gulf Health Council (GHC). The challenge was to publish and submit the large size files to the GHC portal (Taawon) while running against the time. As the team finished the grueling job of publishing the sections
Gulf Health Council file upload for biosimilar product Read More »
Ever since the incorporation, it has been DDReg’s endeavor to provide high quality services to its customers. To achieve this, DDReg has been consistently and regularly working towards improving its quality standards. For more than 6 years now, we have been achieving the high-quality standards set up by ISO 9001:2015, through the global accreditation agency
In a technology-driven era where businesses are increasingly incorporating advanced information and data management tools into their operations, the risk of facing cyber attacks and breaches is also increasing. Additionally, businesses face non-compliance in regulatory and legal requirements when handing information security, and so the demand for transparent information security is on the rise- particularly
Why is an ISO 27001 Certification Important For an Organization? Read More »
