Meranda Parascandola – Page 33

August 29, 2025

Published by Meranda Parascandola at August 29, 2025

Exploring Common CMC-Related Delays in Drug Product Development

Delays in drug development often trace back to overlooked CMC challenges. These technical details—how a drug is made, quality controlled, and tested—shape the path from lab to patient. A strong candidate can stall when formulation or manufacturing plans fall short. Teams that invest early in strategic CMC planning avoid costly […]

August 29, 2025

Published by Meranda Parascandola at August 29, 2025

Understanding Changing Regulatory Demands in Pharma Process Development

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 […]

October 27, 2025

Published by Meranda Parascandola at October 27, 2025

Moving from Human Health to Animal Health: What to Know

If you’re a human-health biotech or pharma company eyeing the animal-health market, you’re not alone. Pet-owner spending, food-animal productivity pressures, and “One Health” thinking have pushed more human-first innovators to explore veterinary indications, either by repurposing an existing asset or launching a dedicated animal program. The opportunity is real, but […]

November 20, 2025

Published by Meranda Parascandola at November 20, 2025

Veterinary CMC Readiness: A Gap Assessment Approach

Chemistry, Manufacturing, and Controls (CMC) data is often one of the most underestimated elements in veterinary drug development. Yet when it comes time to prepare an FDA submission—whether an INAD or a full NADA—incomplete or misaligned CMC information is one of the leading causes of delay. For companies seeking a […]

November 20, 2025

Published by Meranda Parascandola at November 20, 2025

Why More CDMOs Are Targeting Veterinary Clients (and How to Stand Out)

The Contract Development and Manufacturing Organization (CDMO) landscape is evolving—and animal health is quickly becoming one of the most sought-after segments. As pharmaceutical sponsors increasingly focus on strategic outsourcing, many CDMOs that once served only human health are now expanding into veterinary manufacturing to capture a fast-growing market with unique […]

November 20, 2025

Published by Meranda Parascandola at November 20, 2025

How Due Diligence Differs in Animal Health vs. Human Health

Due diligence is a cornerstone of investment and acquisition decisions—but in animal health, the process plays by a slightly different set of rules. While many human health investors are familiar with INDs, CDER, and clinical trial design, the animal health world brings its own regulatory structures, product formats, and commercial […]