CLINICAL SUPPLY PACKAGING RESOURCES

• Is Your Clinical Supply Strategy Ready For EU CTR?

  One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging? 

• Rare Diseases And The Integrated CDMO Support System

  Champion the rare‑disease community by advancing development models built on precision, continuity and global coordination that ensure every dose reaches the patients who need it most.

• Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

  This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.

• Highly Potent, Perfectly Packaged

  Experts explore a project to add a contained manufacturing facility and potent packaging suite by discussing the attention to technical detail required to exceed the required high standards and regulatory controls.

• Global Reach, Biotech Speed: Clinical Packaging, Labeling That Delivers

  By integrating scalable operations, reliable supply chains, and deep regulatory expertise, biotech companies can eliminate bottlenecks, improve efficiency, and accelerate trial execution.

• Clinical Supply Optimization: Process Improvement Accelerates Trials

  A biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.

• Cold Chain Services For Clinical Trial Success

  As innovative, complex therapeutics advance toward clinical trials, properly handling, storing, and packaging temperature-sensitive critical materials is essential to maintain product integrity.