Precise manufacturing. Creative thinking. It takes both to succeed in a competitive marketplace. Vetter Commercial Manufacturing supports your injectable with more than 25 years of expertise in high-quality, state-of-the-art aseptic filling - and experience-based solutions that add value and increase efficiency.
Vetter Commercial Manufacturing
Filling your potential.
Vetter provides complete fill and finish services for aseptically prefilled drug delivery systems including syringes, cartridges, and vials, and specialized technologies such as dual-chamber systems. Our production facilities utilize industry-leading Restricted Access Barrier (RAB) technology, which ensures the required sterility in filling and finishing. Each of our 3 independent commercial facilities includes its own analytical and microbiological testing resources and 100% visual inspection process, and complies with all cGMP standards and FDA guidelines.
Using sophisticated analytical techniques, Vetter’s highly trained analytical quality control staff provides validation of all raw materials, bulk solutions, in-process materials, and finished product. The analytical team is also regularly involved in highly customized, intensive work to guide the transfer of microbiologic and chemical analytical methods. All utilities, cleanrooms, and processes are routinely monitored according to cGMP and FDA requirements.
Vetter provides extended regulatory support services to meet your product’s special requirements after drug approval – such as change announcements or preparing of variation documentation. Our regulatory consulting services are also available to support development of annual product reviews in accordance with EMA and FDA requirements.
During every stage of development, Vetter works closely with you to develop product life cycle management strategies that expand your product’s potential. These strategies may include support for entering new countries and regions, seeking new indications to increase market share, or reformulating your compound for delivery systems that enhance safety and convenience. Our life cycle strategists strive as well as build and maintain your product’s success over the long-term – as well as meet changing health care requirements and regulatory guidelines.