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Treating Clostridium difficile infections using biotherapeutics

Treating Clostridium difficile infections using biotherapeutics

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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 […]

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regulatory publishing

Incorporating plug in tools to facilitate regulatory publishing tasks

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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

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Gulf Health Council file upload

Gulf Health Council file upload for biosimilar product

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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

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Information Security Management System

DDReg receives the ISO 27001:2013 certification for Information Security Management System

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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

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benfits of ISO 27001 Certification

Why is an ISO 27001 Certification Important For an Organization?

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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

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RIMS Tools in Asia Market

Role of Regulatory Information Management Systems -RIMS Tools in Asia Market

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Managing regulatory information for a pharmaceutical product along all stages of its life cycle is a key challenge in the pharmaceutical industry. Now, as more opportunity markets emerge bringing their own stringent regulations and changes in previous regulations, managing regulatory information is becoming increasingly complex which can delay market access for products. Furthermore, information is

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Regulatory Affairs in Pharmaceutical

Role of Regulatory Affairs in the Pharmaceutical Industry

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The pharmaceutical industry is highly regulated using legislations and regulations that bring together administrative, technical, and legal information about a medicinal product. These can be a combination of guidelines, procedures, policies, etc., that pharmaceutical organizations must adhere to, or follow, to get market approval for their products. This way, governments and their relative health authorities

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Pharmacovigilance

India’s New Drugs, Medical Devices and Cosmetics Bill 2022

All Category, Blogs, Medical Device /

Drug laws & regulations in India have roots that are almost 80 years old. India still follows drug laws that were framed in pre-independence time through Drugs & Cosmetics Act – 1940 and Rules 1945. The laws & rules have frequently been amended to address the challenges posed by Indian pharma Industry. However, the basic

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DDReg Foundation Day Celebrates

DDReg celebrates its 13th Foundation Day

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On Friday 1st July 2022, DDReg Pharma wholeheartedly celebrated its 13th Foundation Day. Employees from the Gurgaon, Mumbai, and Hyderabad offices connected virtually to commemorate not only the grand occasion but also each other’s milestones and achievements. The day consisted of fun activities including interactive games and performances by employees such as singing, instruments, poetry,

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