REGULATORY TEAM

At Genex Pharma, we take pride in our proficiency and expertise in meeting all the desired regulatory approvals and requisites for conducting international business as per the country’s guidelines. Our commitment to compliance and regulatory excellence enables us to navigate the complex regulatory landscape with confidence.  

We embrace best practices and industry standards to ensure that our products and services not only comply with regulations but also surpass quality, safety, and efficacy requirements through various ways like Product Development Reports (PDR) and Analytical Method Validation (AMV) process. Moreover, according to the country’s climatic zones, we comply with the stability testing conditions.  

Readily available dossiers, both CTD as well as ACTD for our complete range of products give us a competitive edge, enabling us to register majority of our products and dossiers in various countries and regions across the globe. 

The strong networking with the regulatory authorities and in-depth knowledge reduces turn – around – time in initiating business and achieving faster business momentum. Our commitment to regulatory compliance is unwavering, and it underpins every aspect of our international operations. Thus for their consistent efforts, they’re awarded with GDP certificate.