ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Which Testing Does An Effective Certificate Of Analysis Include?

  Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

• The Gateway Delivery To The Brain

  Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.

• The Challenges And Opportunities Of Real-World Evidence

  The FDA's Real-World Evidence framework addresses challenges in using Real-World Data for regulatory decisions, emphasizing data reliability, bias management, and successful case studies.

• Flexibility And Capability In Pre-Filled Syringes: The Future Of PFS

  Outlined here are the inherent benefits of PFS and how they relate to the delivery of drugs, such as biologics and vaccines, how SARS-CoV-2 could be fueling an explosive increase in PFS demand, and how a partnership with a flexible CDMO is the key to success.

• An Elegant Solution For Delivery Of Acid Sensitive Pharmaceuticals

  Sustained release drug delivery products offer effective therapies in the treatment of serious chronic diseases, and their development requires customized solutions with tunable material properties.

• USP <788> Revisions And Why Packaging Matters More Than Ever

  Prepare for the upcoming USP <788> revisions by strengthening your particulate control strategy to support regulatory compliance, product quality, and patient safety across injectable drug products.

• The Growth Of Sterile Injectables

  Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.

• How Lipid Nanoparticles Overcome Solubility Challenges

  More than 80% of NCEs are poorly soluble compounds. Overcoming this challenge using lipid nanoparticles is essential to move your drug product through the pipeline and into the market.

• Annex 1 Is Not the Ceiling For Compliance; It Is The Foundation

  The sterile manufacturing industry is evolving as regulators adopt broader compliance expectations. Learn how contamination control, risk management, and transparency drive success.

• Addressing Regulatory Challenges For Ophthalmic Combination Products

  Classifying eye drops as combination products complicates approval. Learn how identifying the primary mode of action early and aligning dual quality frameworks prevents costly launch delays.