Meranda Parascandola

Pharmaceutical process development is not a static undertaking. Regulatory expectations continue to evolve, demanding deeper process understanding, enhanced control strategies, and comprehensive documentation throughout the development lifecycle. For companies aiming to bring new therapies to market efficiently and compliantly, staying aligned with these changes is both a challenge and an […]

Investors and strategic partners expect technical risk when evaluating early-stage drug development programs. However, certain CMC (Chemistry, Manufacturing, and Controls) red flags are immediate causes for concern—and can quickly lower valuations, delay deals, or even derail partnerships altogether.  Here are five of the most common CMC issues that investors view as […]

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 […]