Medical Writing

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 …

Enhancing medico-regulatory writing with artificial intelligence Read More »

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 …

Challenges in immunogenicity assessments for biosimilar development Read More »