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biosimilar products guidance for Licensing in Uk Mhra

A summary of the “Guidance on the licensing of biosimilar products”- UK MHRA

The pharmaceutical regulatory landscape in the UK has experienced many changes since Brexit. Several guidelines have been updated for more UK-specific pharmaceutical product regulation. Among these includes the ‘Guidance on the licensing of biosimilar products’ that was first published on the 6th of May 2021 with the aim to outline clear requirements for biosimilar product […]

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Key Regulatory Challenges api manufacturing

An overview on some key regulatory challenges in API manufacturing

The regulatory landscape is consistently evolving as it faces ever-changing guidelines and regulations. On one hand, these patient-centric regulatory changes ensure that safe, efficacious, and high-quality pharmaceutical products reach the market. On the other hand, key stakeholders in the pharmaceutical regulatory environment face significant obstacles. Needless to say, these regulatory challenges are not limited to

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eCTD Publishing and Submission Management

Solutions and best practices in eCTD Publishing and submission management

The electronic transfer of regulatory information and subsequent review of drug applications is now more streamlined after decades of paper-based procedures. The electronic version of the Common Technical Document (CTD), or the eCTD, is now becoming more and more common in life sciences contexts worldwide, particularly in the regulatory landscape. Therefore, organizations must get ready

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Challenges in eCTD Publishing & Submission Management

Challenges in eCTD Publishing & Submission Management

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

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

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

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

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

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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