BLOGS
BLOGS
Exploring Pharmacovigilance Approaches for Biosimilars Market Success
The pharmaceutical field has witnessed a tremendous growth of innovation and success in the past few years. Among these advancements, biosimilars have become essential for improving patient access and reducing…
Understanding Global Cosmetic Regulatory Standards
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…
How Does Outsourcing MAH Responsibilities Impact a Pharmaceutical Company’s Global Expansion Strategy?
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…
Impact of the Digital Revolution on Pharmaceutical Industry
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…
Navigating Challenges and Future Opportunities in Veterinary Regulations
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…
Understanding the Pharmaceutical Regulatory Landscape of Malaysia
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…
How Pharmaceutical Regulatory Consultant Helps Product Registration in the USA
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…
Accelerating Biosimilar Submissions Across 19 Emerging and ROW Markets
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…
Comparing PRIME and EU Pathways: Long -Term Strategy and Global Impact
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…
Understanding the Impact of IVDR on Precision Medicine Development in the EU
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…
Patient Engagement in Healthcare: Current Trends and Future Opportunities
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…
Collaborating for Global Success in Advanced Therapy Medicinal Products (ATMPs)
Advanced Therapy Medicinal Products (ATMPs) are transforming the medical landscape, offering revolutionary treatments for diseases that previously lacked effective solutions. These products include cutting-edge innovations such as gene therapies, somatic…
Navigating the Challenges of Personalized Medicine in Development
The landscape of modern medicine is undergoing a revolutionary transformation, with personalized medicine at the forefront. As we move away from the “one-size-fits-all” approach and embrace treatments tailored to individual…
Leveraging Real-World Evidence to Enhance Post-Marketing Safety Globally
Real-World Evidence (RWE) refers to clinical evidence regarding the usage and potential benefits or risks of a medical product, derived from the analysis of Real-World Data (RWD). RWD encompasses information…
Regulatory Challenges and Opportunities with AI in Drug Development
AI has emerged as a transformative force in drug development, promising to revolutionize how new therapies are discovered, tested, and brought to market. AI technologies are revolutionizing the pharmaceutical landscape.…
How Global Collaboration Can Prevent Drug Shortages in Healthcare
Drug shortages are an escalating global challenge, threatening the effectiveness of healthcare systems worldwide. These shortages occur when the supply of medications—ranging from critical life-saving drugs to essential treatments—falls short…
How Pharmacovigilance is incorporating the concept of Patient Centricity – An Industry-Leading Approach
In healthcare, assuring the safety of medications is equally as vital to developing innovative new treatments. Pharmacovigilance (PV), or “drug safety surveillance”, is the science of detecting, assessing, and preventing…
Evolution of Africa’s Regulatory and Healthcare Landscape
Africa’s healthcare and regulatory landscape have transformed to reflect the commitment of the continent to improve public health and ensure the safety and efficacy of medical products. Understanding this evolution…
Advanced Pharmacovigilance Strategies for Rare Disease Drugs
Rare diseases (also referred to as orphan diseases) are diseases that affect less than 5 in 10,000 people in Europe or fewer than 200,000 people in the United States. Although…
Implementing a Quality by Design (QbD) Approach in Regulatory Submissions
Quality by design is a systematic approach to pharmaceutical development that begins with a predetermined objective and emphasizes product and process understanding and process control based on science and quality…