Navigating the challenges during drug submission preparation
During the submission preparation phase for regulatory approval by national authorities, new drug developments encounter significant challenges. Central to these challenges is the need for accurate and meaningful data from packaging-related and functional testing. This data is essential in demonstrating the safety and performance of a drug product and is critical in reducing potential risks to patients.
The extensive scope of testing includes validating the functionality of the combined product to ensure the system operates as designed. The complexity of these tasks is further compounded by stringent regulatory requirements and the high expectations of authorities, necessitating a rigorous and detailed testing program. This underscores the need for a more streamlined and efficient approach in the submission preparation phase.
Make it easy – functional testing services for the customer submission process
We offer a one-stop-shop solution centered on streamlining testing services to significantly reduce the workload and complexity during your submission preparation. Our accredited and FDA-registered laboratory provides analytical testing solutions supported by the extensive experience and expertise of our personnel. By adhering to stringent documentation standards, we ensure full compliance with regulatory authorities.
Not only do we select and perform the necessary tests, but we also address and swiftly resolve any challenges that arise. These include root-cause identification and improvement recommendations. Our functional tests support performance comparison and design verification according to international standards such as ISO 11040-4, -6, -8, ISO 7886-1, USP <1207> and USP <788>. Typical tests include:
- System characterization related to break-loose and gliding force, needle removal/separation force, RNS/LLA pull-off force, torque, Luer Cone and flange breakage resistance, and skin and septum penetration force.
- Analysis of residual volume, extractable volume, delivered dose, liquid leakage, self-sealing, and dye penetration.
- Analysis of plunger movement and coring/fragmentation.
- Sub-visible and visible particle counting.
How we help streamline your pharmaceutical submission journey
By choosing SCHOTT Pharma as your services partner, you gain access to an experienced team that navigates the complexities of pharmaceutical submissions with ease and expertise, paving a seamless path to regulatory approval while guaranteeing compliance and reliability. This one-stop shop integrates a wide variety of tests into an integrated solution to ensure thorough and efficient evaluation of your product.