CUSTOpharm is a customer-focused service company that provides personalized cost-effective chemistry and manufacturing controls (CMC) and regulatory support to companies with limited resources and those seeking to expand into new areas.
CUSTOpharm has a strong background in product development (developed 54 sterile products to date, 48injectable products, 2 nasal products, 2 oral products, and 2 sterile ophthalmics), manufacturing, and regulatory affairs (specifically as it relates to electronic submissions). CUSTOpharm filed the first eCTD ANDA with the FDA in 2004, have filed over 170 ANDA's since. This background allows us to visualize the "big picture" of our clients' projects with a marketable finished product as the ultimate goal. This "big picture" approach places CUSTOpharm ahead of other competitors, which focus on specific tasks, not the finished product.
CUSTOpharm services include:
In addition to these services, CUSTOpharm also has specialized service programs like The CUSTOpharm Program and products like Pub-Assist to meet clients’ needs.