Pharmaceuticals Archives - Page 2 of 2

2023:A Year of Regulatory Revolution in
Life Sciences

2023: A Year of Regulatory Revolution in Life Sciences 2023 was a whirlwind year for the life sciences industry, with regulatory changes and advancements coming at a breakneck pace. Here's a quick throwback on some of the key highlights: Regulatory Landscape:

Comprehensive Guidelines for the
Development of Drugs and Biological
Products to Combat COVID-19: Industry Insights

Comprehensive Guidelines for the Development of Drugs and Biological Products to Combat COVID-19: Industry Insights The FDA's recommendations concentrate on phases 2 and 3 trials, encompassing critical elements such as trial population, design, efficacy endpoints, safety considerations, and statistical aspects. In

FDA Takes Steps to Improve Efficiency
of PMR/PMC Submissions

FDA Takes Steps to Improve Efficiency of PMR/PMC Submissions The Food and Drug Administration (FDA) has released draft guidance for industry on the use of new Forms FDA 3988 and FDA 3989 to submit information on post-marketing requirements (PMRs) and post-marketing

Navigating the Shifting Tides of
Regulatory Compliance in Life Sciences

Navigating the Shifting Tides of Regulatory Compliance in Life Sciences In the dynamic world of life sciences, pharmaceuticals, and medical devices, staying updated on regulatory trends is essential for success. Let's explore the evolving landscape and how end-to-end regulatory services are

Implementing Good Manufacturing Practice
(GMP) Evidence for Drug Substance (DS)
Manufacturers in Singapore

Implementing Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers in Singapore In its unwavering commitment to ensuring the highest standards of quality for therapeutic products available in Singapore, the Health Sciences Authority (HSA) is embarking on a significant regulatory

Navigating the FDA’s New ANDA
Filing Review Policies: What You Need to Know

Navigating the FDA's New ANDA Filing Review Policies: What You Need to Know The US Food and Drug Administration (FDA) has recently implemented significant updates to its policies regarding the review process for Abbreviated New Drug Applications (ANDAs). This move marks

Navigating Health-Based Exposure Limits
in Pharmaceuticals A Path to Safety
and Compliance

Navigating Health-Based Exposure Limits in Pharmaceuticals A Path to Safety and Compliance In the pharmaceutical industry, health-based exposure limits are crucial for safeguarding against potential health risks. These limits have traditionally been used to protect workers in pharmaceutical manufacturing and are

Navigating Regulatory Change in the
Life Sciences Industry: Key Changes
and Your Roadmap to Readiness

Navigating Regulatory Change in the Life Sciences Industry: Key Changes and Your Roadmap to Readiness In the rapidly evolving life sciences landscape, organizations are finding resilience to be a cornerstone of success, especially in the face of challenges like economic pressures,

Navigating the Pre-IND Meeting: Paving the Path to Drug Development Success

Navigating the Pre-IND Meeting: Paving the Path to Drug Development Success Embarking on the journey of bringing a new drug product to market is a challenging endeavor that requires meticulous planning and adherence to stringent regulatory requirements. One pivotal milestone in

Clarifying Generic Drug Development:
FDA Product-Specific Guidance

Clarifying Generic Drug Development: FDA Product-Specific Guidance The pharmaceutical industry is essential to providing safe and affordable medications for public use. Generic drugs, in particular, provide a cost-effective alternative to their brand-name equivalents to ensure wider access to essential medications. The

Ensuring Regulatory Compliance in Medicinal Product Manufacturing: The Importance of CMC Practices

The Chemistry, Manufacturing, and Controls (CMC) of a medicinal product encompass all the essential information related to the manufacturing process, quality control release testing, product specifications, stability, and the manufacturing facility with its support utilities. CMC regulatory affairs and compliance serve

Choosing the Right US Agent for Life sciences Compliance

Choosing the Right US Agent for Life sciences Compliance Selecting a reliable and experienced US Agent is crucial for life sciences companies seeking a smooth and compliant entry into the US market. In this blog post, we will explore the factors

The Importance of US Agent Services for Lifesciences Companies

The Importance of US Agent Services for Life sciences Companies Foreign companies operating in the lifesciences industry often face complex regulatory requirements when entering the United States market. One crucial aspect of compliance is the appointment of a US Agent. In

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Category: Pharmaceuticals