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US FDA Radiological Health Regulations

Navigating US Regulations in Radiological Health 

Blogs, Regulatory /

Radiological health involves the safe use of radiation in medical diagnosis, treatment, and industrial applications. Its goal is to minimize unnecessary radiation exposure for patients, healthcare workers, and the public. Regulation is critical for managing the risks of ionizing radiation (such as cancer risks from excessive exposure).  As we navigate through 2025, staying informed about […]

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Role of Blockchain and IoT in Drug Development.

Evaluating the Role of Blockchain and IoT in Drug Development

Blogs, Regulatory /

The pharmaceutical industry is undergoing a significant transformation, driven by the need for innovation and efficiency in pharmaceutical drug development. Drug development is a resource-intensive process that can take 10–15 years and cost billions of dollars to bring a medicine to market. One important aspect is the clinical trials, which face many challenges, including data

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South Koreas Regulatory Landscape for drugs

Navigating the Drug Regulatory Landscape of South Korea

Blogs, Regulatory /

With its rapidly growing pharmaceutical industry and stringent regulatory requirements, South Korea is becoming a key global player. But for pharmaceutical companies, navigating this landscape requires strategic planning and compliance expertise.  The Ministry of Food and Drug Safety in South Korea (MFDS), previously known as the Korean Food and Drug Administration, serves as South Korea’s

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Global Cosmetic Regulations A Guide for Cometic Products

Understanding Global Cosmetic Regulatory Standards

Blogs, Regulatory /

The global cosmetic industry is a complex and rapidly growing landscape where regulatory compliance is fundamental in ensuring product safety, efficacy, and market access. As cosmetic products cross borders, manufacturers must comply with country-specific regulations from ingredients safety to product labeling. These regulations protect consumers and set the standards that businesses must follow to enter

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Digital Revolution on Pharmaceutical Industry

Impact of the Digital Revolution on Pharmaceutical Industry

Blogs, Regulatory /

The pharmaceutical industry, long characterized by traditional research and manufacturing practices, is currently undergoing a profound revolution. Led by advanced analytics, artificial intelligence (AI), blockchain, and other cutting-edge technologies, digital innovations are revolutionizing drug discovery, manufacturing, marketing patient care services and regulatory oversight, with real world examples and extensive research supporting these changes. This blog

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Veterinary Regulations

Navigating Challenges and Future Opportunities in Veterinary Regulations

Blogs, Regulatory /

The field of veterinary medicine is rapidly advancing, driven by new therapies and technologies as well as increasing public health concerns about antimicrobial resistance (AMR). Regulatory agencies around the world–such as FDA, EMA and regional bodies–are adapting quickly to these changes, with regulatory frameworks constantly adapting to ensure veterinary medicinal products (VMPs) meet stringent safety

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Malaysia Pharmaceutical Regulatory Pathway

Understanding the Pharmaceutical Regulatory Landscape of Malaysia

Blogs, Regulatory /

Malaysia’s pharmaceutical industry is a rapidly growing sector, driven by increasing healthcare demands, advancements in medical research, and government support. For pharmaceutical companies looking to enter the Malaysian market, understanding the regulatory framework is crucial. The National Pharmaceutical Regulatory Agency (NPRA) plays a key role in overseeing drug approvals, quality standards, and compliance with national

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Registered Products in USA through Pharma Regulatory Consultant

How Pharmaceutical Regulatory Consultant Helps Product Registration in the USA

Blogs, Regulatory /

The pharmaceutical regulatory consultants are specialists in FDA regulations and can guide companies through the registration process for their products making sure that all the required documentation, clinical data, and measures to ensure compliance are in the correct order. Over the decades, the regulatory framework in the United States has advanced and driven by scientific

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PRIME vs. EU pathways: Strategy, global impact, and drug development insights

Comparing PRIME and EU Pathways: Long -Term Strategy and Global Impact

Blogs, Regulatory /

In the European Union (EU), the European Medicines Agency (EMA) has implemented several expedited regulatory pathways, notably the PRIority MEdicines (PRIME) scheme, to facilitate the development and approval of promising medicines. Launched in March 2016, the PRIME scheme aims to enhance support for the development of medicines that target an unmet medical need. In addition

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impact of vitro diagnostic medical device regulation in EU

Understanding the Impact of IVDR on Precision Medicine Development in the EU

Blogs, Regulatory /

The European Union introduced the In Vitro Diagnostic Regulation (IVDR), an elaborate regulatory framework intended to increase safety, performance and reliability of in vitro diagnostic (IVD) medical devices. Replacing its predecessor (IVDD), EU IVDR requires stricter requirements for compliance while placing greater emphasis on clinical evidence, risk classification and post market surveillance. Precision medicine, an innovative

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