The 7th of April 2022 marked the 74th anniversary of the founding of WHO in 1948 which is celebrated annually as ‘World Health Day’. Each year draws attention to a specific health topic of concern to people all over the world. The onset of the pandemic has created history and has affected billions of people […]
RegTech focuses on technologies that may facilitate the delivery of regulatory requirements more efficiently and effectively than existing capabilities. The global adoption of RegTech is a result of increased regulatory scrutiny, compliance costs, development of artificial intelligence, evolution of data science and increasing demands regarding cost-effective compliance solutions. With ever changing regulatory requirements, pharmaceutical organizations
DDReg’s RegTech space: your regulatory solution for achieving rapid market access Read More »
The healthcare ecosystem is driven by several factors. Government vision, successful partnerships, modern legislation, and adoption of innovation are some of the most crucial ones from a regulation point of view. Regulatory affairs (RA) bridge the gap between regulatory authorities and market access for drugs allowing patient empowerment by increasing drug availability. With ever-changing laws,
DDReg Pharma: Silver Sponsors of the 7th GCC Pharma Summit 2022, Dubai, UAE Read More »
Biologic medicinal products, particularly biosimilars, have revolutionized the treatment of chronic conditions. As biologic products lose patent protection, biosimilars emerge as more readily accessible treatment alternatives. In the European Union (EU), the European Medicines Agency (EMA) is responsible for product approval. The EMA was the first regulatory authority to establish a regulatory framework for biosimilars
Biologics development & regulatory approval – EMA perspective Read More »
A biological drug (or biologic) is one that is produced from a living organism or contains components of a living organism. They have become indispensable tools in modern medicine, for treatment of life-threatening conditions. With an aging population and a growing demand for treating chronic conditions, biologic use is on the rise. However, they are
Biosimilarity and Interchangeability in the MENA region Read More »
Smart regulatory processes and regulatory intelligence have evolved over past decade. Human race has finally transferred its knowledge and experience to machines for smart processing. Automation of processes, use of AI & ML have gained a lot of traction and are now the new competitive battleground. Technology is keeping pace with the rapidly changing regulatory
DDReg enters into RegTech Space Read More »
GCC Regulatory Affairs Pharma Summit is an annual event that provides platform for pharmaceutical regulatory experts and industry professionals in the GCC region to share insights and discuss about the latest updates in the pharmaceutical regulations. In its 2022 edition, Neeti Pant from DDReg shall be one of the invited speakers to deliberate on “Biosimilar
DDReg Participates in the 2022 edition of GCC Regulatory Affairs Pharma Summit in Dubai Read More »
Over the last five years, biosimilars have progressively gained traction. Global sales are expected to more than double to $15 billion by the early 2020s, with emerging markets accounting for $5 billion to $8 billion. Multinational organizations seeking their entrance into emerging markets of the world focus on the biologic-treatment rates of countries and are
Biosimilars in the Emerging World Read More »
In 2019, the African Union’s Bureau of Heads of State and Government approved a new Treaty for the establishment of the African Medicines Agency (AMA) to improve countries’ ability to regulate medical products. It appeared like AMA will become a reality now that 15 African Union Member States have ratified the Treaty in recent months.
African Medicines Agency Read More »
Integral health integrates traditional treatment in a coordinated way with alternative medicine. Multimodal interventions, which combine two or more interventions such as conventional medicine, lifestyle changes, physical rehabilitation, psychotherapy and complementary health approaches in various combinations, with an emphasis on treating the whole person rather than, for example, one organ system, are also emphasized in
Integrative Medicine Read More »
