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QbD in Regulatory Affairs Submission

Implementing a Quality by Design (QbD) Approach in Regulatory Submissions

Blogs, Regulatory /

Quality by design is a systematic approach to pharmaceutical development that begins with a predetermined objective and emphasizes product and process understanding and process control based on science and quality risk management. This method is redesigned to improve drug safety, efficacy, and overall quality by systematically identifying and managing critical quality attributes (CQAs) and critical […]

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Regulatory Framework for Vaccines in United States and Europe

Blogs, Regulatory /

Vaccines are among the greatest achievements of modern medicine, safeguarding millions from infectious diseases. With the rapid evolution of global healthcare needs, particularly during pandemics, vaccine regulations have become more critical than ever. Both the United States and the European Union (EU) maintain stringent frameworks to ensure the safety, efficacy, and availability of vaccines. While

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Medical Device Regulations in the United States

Medical Device Regulations in the United States

Blogs, Medical Device, Regulatory /

Medical devices are indispensable tools that help improve the ability to diagnose and treat illnesses, both simple and complex in nature. As technological disruptors become increasingly available in the healthcare industry, medical device manufacturers are developing more advanced devices which necessitates a robust regulatory framework. Among the regulatory agencies, the United States Food and Drug

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Regulatory Framework for mRNA-Based Therapeutics

Exploring Regulatory Compliance for mRNA-Based Therapeutics

Blogs, Regulatory /

The rise of messenger RNA (mRNA) technology has transformed the pharmaceutical industry, as shown by its recent creation and use during the COVID-19 pandemic. mRNA therapeutics use synthetic RNA molecules to direct cells to make specific proteins that can prevent or treat illness, unlike conventional drugs that deliver protein directly to the body. mRNA serves

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Complete Guide to Regulatory Pathways for Biosimilars in the EU and US

A Complete Guide to Regulatory Pathways for Biosimilars in the EU and US

Blogs, Regulatory /

In the dynamic world of pharmaceuticals, biosimilars are reshaping treatment paradigms, offering cost-effective alternatives to biologic therapies while maintaining high-quality standards. The successful development and commercialization of biosimilars hinge on navigating complex regulatory pathways. This guide provides an in-depth look into the regulatory frameworks governing biosimilars in the European Union (EU) and the United States

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Pharmaceutical Regulatory Trends and Challenges Across the Asia-Pacific Region

Pharmaceutical Regulatory Trends and Challenges Across the Asia-Pacific Region

Blogs, Regulatory /

The Asia-Pacific (APAC) region is a rapidly growing hub for pharmaceutical innovation and generic drug development. The increase in demand for generic drugs is due to their low cost and equivalent safety and efficacy to branded drugs. The APAC region incorporates a wide range of regulatory frameworks, from highly developed frameworks of stringent regulatory authorities

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Risk Evaluation and Mitigation Strategies for US Drug Development

Risk Evaluation and Mitigation Strategies (REMS) for US Drug Development

Blogs, Pharmacovigilance, Regulatory /

Risk Evaluation and Mitigation Strategies (REMS) is a drug safety program required by the US FDA for certain medicines that are associated with safety concerns. They typically accompany applications to the US FDA, like New Drug Applications, Biologics License Applications, or Abbreviated New Drug Applications (ANDA), that describe drug safety and ensure that the drug’s

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Navigating Regulatory Pathways for Regenerative Medicines

Regulatory Landscape of Regenerative Medicines

Blogs, Regulatory /

Regenerative medicine is a field that has emerged as a new component of modern medicine/healthcare by introducing therapies that repair or replace damaged tissues and organs through innovative approaches, including stem cells, gene therapy, and extracellular vesicles. Having the potential to address medical needs, regenerative medicine also presents unique regulatory challenges given the lack of

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Global market access in pharma

Tackling Global Market Access Barriers in Pharma Regulation

Blogs, Regulatory /

A pharmaceutical product’s journey through its development lifecycle, all the way to commercialization stage, is relatively complex. What adds more to the complexity is the labyrinth of regulatory requirements, which vary from region to region. Therefore, pharmaceutical companies that want to introduce their innovative therapies face several obstacles as they navigate through the regulatory intricacies

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FDA Form 483 Warning Letter Inspection Report

How to Effectively Respond to FDA Form 483 and Warning Letters

Blogs, Regulatory /

For companies in regulated industries like pharmaceuticals, biotechnology, and medical devices, regulatory inspections are an integral part of operations. An FDA inspection may feel daunting, but it’s a critical mechanism to ensure compliance with standards (such as Good Manufacturing Practices) to safeguard public health and safety. When compliance gaps are identified, the FDA communicates its

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