Medical Writing

Biotechnology products that are derived from cell lines are associated with a certain degree or risk of viral contamination. These risks can be attributed to source cell line contaminations or exogenous introduction of adventitious virus; indeed these risks need to be reduced as contamination can have major consequences. Virus testing programs have supported in assuring

Comprehending the Key Components of Formal Meetings for Biosimilar Development with the FDA Introduction The development and approval process for biosimilar or interchangeable biosimilar product development is a complex journey. It requires close collaboration between pharmaceutical companies and global regulatory consulting authorities. In the United States, the Food and Drug Administration (FDA) plays a pivotal

Navigating the Paediatric Investigation Plan and its Significance in the Development of Medicinal Products. The development and authorization of medicinal products for paediatric use are essential for ensuring the health and well-being of children. However, conducting clinical trials involving children requires a distinct set of considerations and ethical standards. To address these challenges, the concept

The importance of recruiting diverse patients for clinical trials in pharmaceutical development and approval has been highlighted by various stakeholders. Regulatory agencies have been proactive in establishing policies and providing guidelines. These promote practices which support diversity in clinical trials to ensure greater population representation. An example is the US FDA’s Racial and Ethnic Diversity

Medico-regulatory writing is an important part of regulatory affairs in the Pharmaceutical and Life Sciences industry. Regulatory standards are becoming more stringent in terms of data requirements as a result of ever-changing regulations. So, it is crucial to incorporate the most updated and precise medical information into regulatory applications for pharmaceutical product approval, and to

The biosimilar market is rapidly growing across the globe as patents and exclusivities for biologic products approach their expiration dates. Indeed, biosimilars offer more access due to their affordability which is a key driving factor for market development, particularly in emerging markets with growing economies. However, biosimilar development is prone to many challenges, through all