In addition to the services offered by CUSTOpharm, Contract Manufacturing and specialized software (like Pub-Assist) are also available.
CUSTOpharm is committed to its clients to assist them in meeting their CMC and regulatory needs to develop drug products in the most efficient, effective and economical ways possible. As our clients have specialized needs and requirements, we seek to provide innovative solutions to meet those needs.
CUSTOpharm has identified a need and an interest with pharmaceutical companies for manufacturing facilities when in-house capabilities do not exist or cannot meet demand. In response to this, CUSTOpharm evaluates Contract Manufacturing capabilities for sterile products. This cost effective strategy allows smaller and virtual pharmaceutical companies to have access to contract manufacturing at prices similar to companies that possess their own manufacturing facilities without the need to cover the large overhead associated with maintaining or opening a facility. Please visit our Contract Manufacturing page or contact us for additional information regarding this service.
CUSTOpharm identified a need for automated software to assist with eCTD regulatory submissions such as addressing frequently required tasks and common publishing errors like invalid hyperlinks, invalid bookmarks, initial page layout, etc. In response to this, CUSTOpharm has developed a software program, Pub-Assist, for use by regulatory professionals to automate common tasks and ensure compliance with these common errors. Pub-Assist is available as a free trial version and a full-version for purchase. Visit the Pub-Assist website for available downloads and additional information.