Meranda Parascandola

The global pharmaceutical supply chain is more fragile than ever. COVID-19, geopolitical tensions, raw material shortages, tarrifs and logistics disruptions have exposed vulnerabilities that can directly impact API availability and costs.  In this blog, we explore how to build a resilient API supply chain—and why proactive planning matters more than […]

Process validation is a critical milestone in the drug development journey, particularly for API manufacturing. An effective validation strategy not only meets regulatory expectations—it ensures a controlled, well-understood process capable of consistently delivering high-quality API throughout the product lifecycle.  But process validation isn’t a one-size-fits-all exercise. Requirements evolve from early […]

Regulatory starting material (RSM) selection and justification can make or break your API CMC strategy. Regulatory authorities such as the FDA and EMA carefully scrutinize RSM designations, and inadequate justification is a frequent cause of information requests, delayed approvals, or even refusal to file.  Selecting the wrong starting material—or failing to justify it properly—can trigger extensive […]

At the core of every successful drug development program lies a reliable, scalable Active Pharmaceutical Ingredient (API) manufacturing process. From early discovery chemistry to commercial supply, designing an API process that evolves efficiently through each phase is critical to meeting regulatory expectations, clinical timelines, and commercial goals.  Yet many programs […]