development, Author at DDReg pharma

DDReg’s RegTech space: your regulatory solution for achieving rapid market access

All Category, Insights, Regulatory / development

DDreg 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 […]

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ddregpharma silver sponors of the 7th gcc pharma summit 2022 in dubai and UAE

DDReg Pharma: Silver Sponsors of the 7th GCC Pharma Summit 2022, Dubai, UAE

All Category, News and Events / development

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,

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Biologics development & regulatory approval – EMA perspective

All Category, Insights, Regulatory / development

Biologics development in Biologic medicinal products, particularly biosimilars, has 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

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Biosimilarity and Interchangeability in the MENA region

All Category, Insights, Regulatory / development

A biological drug (or Biosimilar) 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 the 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

DDReg enters into RegTech Space

All Category, News and Events / development

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

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DDReg Participates in the 2022 edition of GCC Regulatory Affairs Pharma Summit in Dubai

All Category, News and Events / development

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

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Biosimilars in the Emerging World

All Category, Insights, Regulatory / development

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

DDReg opens entity in the USA

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As one of the leading pharmaceutical Regulatory consulting firms, DDReg is involved in a wide variety of pharma regulatory assignments from organizations across the globe for regulated and emerging markets. Today, we are honored to announce to you that DDReg has taken the next big step and opened its new entity DDReg Pharma Inc. in Wilmington,

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All About African Medicines Agency

All Category, Insights, Regulatory / development

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.

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What is Role of Integrative Medicine in Healthcare?

All Category, Insights, Pharmacovigilance / development

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

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Author name: development