Regulatory, holds a commitment to compliance, safety and well-being of human beings at CTX .
Our Regulatory Affairs team ensures that our products meet and exceed regulatory requirements in every market where we offer and sell.
Our team of experienced regulatory professionals stays up-to-date on the latest regulatory requirements and industry standards, ensuring that our products are compliant with all applicable regulations. We work closely with regulatory authorities and industry organizations to ensure that our products are up to the standards of use in all relevant markets.
Our Regulatory Affairs team also plays a key role in the development and registration of new products. We work closely with our R&D and Quality teams to ensure that our products meet all regulatory requirements, from initial development through to commercialization and post-marketing surveillance.
All standard CTX products have Drug Master File( DMF ) / Active Substance Master File ( ASMF ) in eCTD format ( Electronic Common Technical Document) .
The team believes and focuses on submission of high-quality DMFs inclusive of necessary data and registration documents. They emphasize on using data & experience driven knowledge to analyze regulatory trends to continuously improve the content submissions. Lastly provide necessary support to customers and Health Authorities.
The majority of products are filed in either or several of the below countries and reviewed by their health agencies which guarantee a robust and validated manufacturing procedures, correctly defined Key Starting Material(KSM), right operational cGMP conditions, validated analytical methods, data integrity and traceability.
Transparency & Communication
At CTX Lifesciences, we are committed to transparency and open communication with our clients. Our team works closely with our clients and partners to ensure that they have the information and documentation they need to meet their own requirements.
Contact us today to learn more about our capabilities and how we can help you achieve your manufacturing and regulatory goals.