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Challenges in eCTD Publishing & Submission Management

Challenges in eCTD Publishing & Submission Management

Blogs, Publishing /

Electronic regulatory submissions have their roots in the late 1980s and have significantly developed over the last few years, especially in key markets. The migration from paper-based submissions to electronic submissions has revolutionized the management and exchange of regulatory information. Additionally, it enables more efficient review processes and enhances the lifecycle management of submissions. In […]

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World Arthritis Day

Adalimumab as a treatment choice for Rheumatoid Arthritis- a pharmacoeconomic perspective

Blogs /

Arthritis is an inflammatory condition that affects people worldwide leading to disabilities and decreasing the quality of life. Rheumatoid Arthritis (RA) is the most prevalent inflammatory arthritis that has triggered a revolution of treatment options over the last few decades. Though there is currently no cure for the condition, treatment regimens focus on alleviating symptoms,

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EU Biosimilar medicines can be interchanged

European Medicines Agency: Biosimilar medicines can be interchanged

Blogs, Regulatory /

A biosimilar medicine is one that demonstrates high similarity to another biological medicinal product that has already been approved- this is also known as the ‘reference product’. Interchangeability refers to using one medicinal product instead of another provided the therapeutic intent is the same. In this context, interchangeability is the medicinal product being substituted by

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Cardiovascular Medical Device Regulation in FDA

Overview on Cardiovascular Medical Device Regulation by the FDA

Blogs, Medical Device, Regulatory /

According to the World Health Organization (WHO), cardiovascular diseases (CVD) are the leading cause of death around the world. In 2019, nearly one-third of all global deaths were attributed to CVD-related death; 85% were as a result of stroke and heart attack (1). Over the last few decades, cardiovascular devices have emerged as an important

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contraceptive better and safe family planning World Contraception Day

Increasing access to contraceptive implants for better and safe family planning

Blogs, Regulatory /

Access to contraceptive options for reproductive health helps women in achieving their reproductive goals by allowing them to plan and have safe pregnancies. Spacing pregnancies is beneficial for maternal health and allows women to pursue other priorities such as education or work. In developing countries, maternal morbidity and mortality rates are relatively high and evidence

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Pharmacovigilance Services in DDregpharma

Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety

Blogs, Pharmacovigilance /

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

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EU Clinical Trial Information System

Understanding the EU Clinical Trial Information System

Blogs, Regulatory /

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

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Treating Clostridium difficile infections using biotherapeutics

Treating Clostridium difficile infections using biotherapeutics

Blogs, Regulatory /

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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