DDReg pharma

Quailty Driven by Passion

Submit Query

Author name: development

Regulatory Framework for Vaccines in United States and Europe

All Category, Blogs /

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 […]

Regulatory Framework for Vaccines in United States and Europe Read More »

Medical Device Regulations in the United States

Medical Device Regulations in the United States

All Category, Blogs, Medical Device /

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

Medical Device Regulations in the United States Read More »

Regulatory Framework for mRNA-Based Therapeutics

Exploring Regulatory Compliance for mRNA-Based Therapeutics

All Category, Blogs /

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

Exploring Regulatory Compliance for mRNA-Based Therapeutics Read More »

Pharmacovigilance Systems in the MENA Region case study

Developing Pharmacovigilance Systems in the MENA Region

Case Studies, Regulatory /

Customer Requirement: A regional regulatory authority in the MENA region sought to address critical gaps in their pharmacovigilance (PV) systems to enhance drug safety monitoring for a portfolio of their products, across the region. The key objectives of the PV system were as follows: Establishing robust PV systems in underdeveloped regions Aligning PV standards with

Developing Pharmacovigilance Systems in the MENA Region Read More »

How Real-World Data Is Transforming Pharmacovigilance

Insight into How Real-World Data Is Transforming Pharmacovigilance

Insights, Pharmacovigilance /

Pharmaceutical companies are in a period of great development and transformation through information technology and data science. Traditionally, pharmacovigilance processes evolved out of data that came from clinical trials and regulatory submissions, open for quite a while now to involve new dimensions with real-world data. Real-world data (RWD) is a collection of insights derived from

Insight into How Real-World Data Is Transforming Pharmacovigilance Read More »

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

All Category, Blogs /

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

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

Pharmaceutical Regulatory Trends and Challenges Across the Asia-Pacific Region

Pharmaceutical Regulatory Trends and Challenges Across the Asia-Pacific Region

All Category, Blogs /

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

Pharmaceutical Regulatory Trends and Challenges Across the Asia-Pacific Region Read More »

Risk Evaluation and Mitigation Strategies for US Drug Development

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

All Category, Blogs, Pharmacovigilance /

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

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

Pharmacovigilance in Mexico

Exploring Pharmacovigilance Processes in Mexico

Blogs, Pharmacovigilance /

The healthcare landscape of Latin America is evolving with pharmacovigilance taking the spotlight to ensure patient safety and regulatory compliance. While there are many contenders of this region, Mexico standards out as a key player with its proactive approach to adverse event monitoring and international alignment that is shaping the future of drug safety in

Exploring Pharmacovigilance Processes in Mexico Read More »

Navigating Regulatory Pathways for Regenerative Medicines

Regulatory Landscape of Regenerative Medicines

All Category, Blogs /

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

Regulatory Landscape of Regenerative Medicines Read More »