Marketing Authorisation Holder (MAH) refers to a person or company that has been granted permission to market a pharmaceutical product within a specific country. MAHs are subject to a number of regulatory requirements and ensure pharmaceutical products meet stringent safety and quality standards. As regulatory frameworks are becoming more stringent, many companies are turning to […]
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
Impact of the Digital Revolution on Pharmaceutical Industry Read More »
Middle Eastern pharmaceutical companies are increasingly prioritizing innovation, amid significant regulatory reforms and harmonization efforts. The region encompassing a diverse range of countries, presents both challenges and opportunities for companies aiming to enter these markets. In this Blog, we explore the key elements of the evolving regulatory frameworks in middle east. Fragmented and complex regulatory
Insights into the Pharmaceutical Regulatory Framework of the Middle East Read More »
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
Navigating Challenges and Future Opportunities in Veterinary Regulations Read More »
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
Understanding the Pharmaceutical Regulatory Landscape of Malaysia Read More »
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
How Pharmaceutical Regulatory Consultant Helps Product Registration in the USA Read More »
Customer Requirement: A biopharmaceutical company aimed to submit 19 biosimilar applications across various emerging and Rest of the World (ROW) markets within a short timeframe. The company required a regulatory strategy that addressed potential gaps, identified the most efficient submission pathways, and aligned with diverse regulatory expectations to ensure successful and timely approvals. Problem Statement
Accelerating Biosimilar Submissions Across 19 Emerging and ROW Markets Read More »
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
Comparing PRIME and EU Pathways: Long -Term Strategy and Global Impact Read More »
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
Understanding the Impact of IVDR on Precision Medicine Development in the EU Read More »
For years, the focus of healthcare development and delivery has been on treatment and outcomes, often with limited input from patients. However, there is now a growing recognition that patients should not just be passive recipients of care—they should be active participants in their own healthcare journey. This patient-centered approach is transforming the way drugs
Patient Engagement in Healthcare: Current Trends and Future Opportunities Read More »
