Quality Testing involves developing a Quality Management System of your drug substance and drug product.
Kamat Pharmatech can demonstrate quality of effective systems to be used in pre-clinical and clinic studies as well as manufacturing by verifying such protocols written. Kamat Pharmatech provides clients with studies related to ICH 10 "Pharmaceutical Quality Systems" which can provide important data when filing.
Developing a QMS for you product is very important when it comes to commercialization, thus studying and preparing this system can start during initial stages. Even though during initial stages the product is still developing, understanding such Quality Aspects early can help tremendously when it comes to final stages. |