11.26.25 -- FDA PreCheck Implementation Recommendations

Get informed about the essential components of a robust RFP and proactive strategies to minimize scope creep for a smoother, more efficient, and more successful collaboration with your CDMO.

Determining a drug candidate’s probability of commercial success is a most significant phase in the drug development process. There is no room for error.

Discover the full benefits of terminal sterilization, how it differs from aseptic manufacturing, and its level of compatibility with your product. Case study included.

A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

Delve into the evolving landscape of pediatric dosage forms, with a focus on how ODTs are emerging as a specialized and practical drug delivery system for children.

Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.

Here, we demonstrate how adding small amounts of SYLOID® mesoporous silica to Cholesterol before jet milling can enhance processing efficiency, boost yield, and improve micronization performance.

When preparing for IND submission, developers must consider multiple components. Explore tips for optimizing your early development program and the benefits of housing all activities under one roof.

Manufacturing complex and highly potent ADC treatments presents unique challenges. Take an insider's look at how these treatments progress from development to commercialization.

In this presentation, Dr. Srinivasan Shanmugam provides key strategies for selecting the right CDMO, reducing costs, accelerating timelines, and ensuring product success.

Backed by proven technical expertise and an extensive global network, we deliver premium manufacturing to support the lightspeed delivery of life-changing therapies.

As the largest GMP product testing network, we ensure seamless regulatory acceptance, rigorous quality, and personalized service from starting materials to finished product testing.

Our network, spanning across nine manufacturing sites in five countries, is well-equipped to support your discovery, preclinical, clinical, and commercial programs for New Chemical Entities (NCEs).