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Pharma Follows Moving Demographics CMC ConsultinghealthcarePharmaceutical Industry
June 19, 2025

Pharma Follows Moving Demographics

Changing Demographics Are Reshaping the Pharmaceutical Industry Demographic changes are transforming the pharmaceutical landscape, influencing everything from drug development priorities to global market dynamics. The increasing median age of populations, declining birth rates, and the rapid evolution of emerging economies present both challenges and strategic opportunities. In this context, agile CMC guidance and advanced digital solutions have become critical differentiators for pharmaceutical companies aiming to stay competitive. Aging Populations and the Demand for Chronic Disease Treatments Global populations are rapidly shifting toward an older median age. Over the next 75 years, the population of those aged 65 and older is projected to nearly quadruple from 650 million to an estimated 2.5 billion. This trend exacerbates demand for therapies targeting: Cardiovascular diseases (CVDs): As the leading global cause of death, CVDs continue to drive demand for advanced therapies and long-term monitoring technologies. The risk of CVD increases from about 40% in 40-59 years to about 75% from 60-79 in men and…
Best Practices for Evaluating Potential Nitrosamines in Pharmaceutical Ingredients CMC ConsultingPharmaceutical DevelopmentPharmaceutical ManufacturingPharmaceutics ProcessQuality Assurance
April 22, 2025

Best Practices for Evaluating Potential Nitrosamines in Pharmaceutical Ingredients

Introduction Nitrosamines have been identified as potential impurities in pharmaceuticals, raising significant concerns due to their carcinogenic properties. Regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have intensified scrutiny on nitrosamine contamination in drug products, prompting manufacturers to implement risk assessment and mitigation strategies.   Sources of Nitrosamines in Pharmaceuticals Nitrosamines can form through various pathways, often as unintended byproducts of chemical synthesis, degradation, or interactions between raw materials. One common source is the reaction between secondary or tertiary amines with nitrosating agents (e.g., nitrites, nitrogen oxides) under mildly acidic or high-temperature conditions. APIs containing amine moieties or manufactured using amine-based reagents are particularly susceptible to forming Nitrosamine Drug Substance-Related Impurities, or NDSRIs. Additionally, contaminated solvents, catalysts, or excipients—such as lubricants or dyes—can introduce nitrosamine precursors into the production process. Cross-contamination from equipment or recycled materials may also contribute to the problem. After synthesis, nitrosamines can form during storage if drug products are…
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Who Needs CMC Consultants? You do. CMC ConsultingPharmaceutical ConsultantPharmaceutical Development
February 23, 2023

Who Needs CMC Consultants? You do.

The pharmaceutical industry is a highly regulated field that requires attention to detail at every stage of product development. The Chemistry, Manufacturing, and Controls (CMC) aspect of drug development is critical, as it involves ensuring the safety, quality, and efficacy of the final product. CMC consultants are professionals who specialize in providing expert advice and guidance in this field, and they can be an invaluable asset to pharmaceutical companies throughout the development process. Regulatory Compliance One of the primary benefits of hiring a pharmaceutical CMC consultant is their expertise in regulatory compliance. The pharmaceutical industry is heavily regulated, and there are numerous guidelines and regulations that companies must adhere to in order to bring their products to market. CMC consultants are well-versed in these regulations and can help companies navigate the complex regulatory landscape, ensuring that their products meet all the necessary requirements. Cost-Effectiveness Developing a new drug can be a costly and time-consuming process. Pharmaceutical CMC consultants can help…