Combination products are subject to specific FDA regulations related to their constituent parts, meaning components must be addressed individually. Human factor and clinical study considerations also need to be taken into account for combination products.
Combination products must follow current GMP guidance, and as with regulatory demands, cGMP requirements apply to constituent parts.
Combination products require a special FDA marketing application. Following this guidance is key to a streamlined process.
Choosing the right partner for development
Partnering with a leader who is experienced in developing combination products can be invaluable when navigating special regulatory processes. Along with regulatory know-how, the following criteria should be considered when selecting a partner.
- A successful track record in cartridge development
- Capabilities in manufacturing processes
- Capabilities in cartridge filling – clinical and commercial
- Selection of packaging materials
- A manufacturing process that ensures tight product specifications
Cartridges require a filling and pen assembly solution. A single point of contact can simplify accountability and response from your partner.
Look for a partner who offers a full range of services, customized packaging development, secondary packaging options, and expertise in complex packaging.
Vetter is your partner for cartridges
As a global expert, Vetter has a successful track record in bringing cartridges to market, with several cartridge products currently in development. With 40+ years of experience, Vetter understands the many challenges posed by combination products.
As one of only a small number of CDMOs able to develop assembly processes for pen devices, we provide a full scope of cartridge and pen platforms, including clinical and commercial offerings. Look to Vetter to make the most of your cartridge-pen combination product.