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 »
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
Role of Regulatory Information Management Systems -RIMS Tools in Asia Market Read More »
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
Role of Regulatory Affairs in the Pharmaceutical Industry Read More »
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
India’s New Drugs, Medical Devices and Cosmetics Bill 2022 Read More »
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,
DDReg celebrates its 13th Foundation Day Read More »
The pharmaceutical industry is one that is constantly growing and simultaneously facing challenges in Quality Management Maturity Program in US FDA. The onset of the pandemic has brought new obstacles that require immediate attention and innovative solutions. Quality assurance (QA) is a routine measure that ultimately ensures patient safety by making sure all pharmaceutical products
Quality Management Maturity Program by the CDER of the U.S. FDA Read More »
Technological disruption is rapidly occurring across all industries. In the pharmaceutical industry, technological contenders are gradually transforming the landscape of drug development, clinical trials, and pre-clinical phases. Indeed, this holds true for Transformation Pharmacovigilance and drug safety monitoring. Though the area of the industry is niche and highly regulated, hence the apprehension in incorporating technology
Technological Transformation in Pharmacovigilance Read More »
In an era of technological advancement, and easy access to such disruptors, pharmaceutical organizations are increasingly looking to outsource their solutions to enhance efficiency and reduce cost. Inevitably, there are many benefits to Regulatory Compliance Outsourcing in the pharmaceutical industry that include operational control, faster time-to-market, increased flexibility & revenue, quality production and ultimately lead
Regulatory Compliance Outsourcing Solutions Read More »
