Once regulatory direction is clear, the next step is formulation development—the heart of generic product success. But remember, formulation is not just about blending ingredients. It’s a strategic and scientific process. The goal is not only to match the innovator product (RLD), but to ensure your formulation is bioequivalent, manufacturable, stable, and regulatory compliant. Here’s…
In generic drug development, technical skills alone are not enough. What truly ensures timely success is strong regulatory planning—right from Day 1. Before you even begin pre-formulation work or touch any excipient, you must sit with your Regulatory Affairs team and carefully plan how the product will be registered. This includes understanding FDA requirements, patent…
he 22 sections of an ANDA (Abbreviated New Drug Application) refer to the structured format used for submission to the USFDA, typically following the CTD (Common Technical Document) format. Here’s a simplified list based on how the “Handbook of Pharmaceutical Generic Development” and USFDA expectations outline it: Key Components of the 22 Sections (Non-CTD Format…
The Common Technical Document (CTD) is a critical component of regulatory submissions, and presenting precise stability data ensures compliance and accelerates approval timelines. Beyond the usual challenges, there are advanced areas that pharmaceutical companies should address to achieve excellence in their submissions. Key areas to focus on for a superior stability data submission Failure to…
Forced degradation studies are more than a regulatory checkbox—they are a cornerstone of quality assurance, designed to reveal the intrinsic stability of a molecule and its behavior under stress. Yet, their potential is often underutilized due to common yet avoidable pitfalls. Key Insights into Frequent Challenges Inadequate Stress Conditions The art of forced degradation lies…
Regulatory excellence lies in the details. Minor oversights in stability and analytical sections can trigger major delays or rejections. exploring three critical but often missed pitfalls: Missing Microbial Limits Justification in Stability for Non-Sterile Products Even non-sterile formulations must maintain acceptable microbial limits throughout shelf life. Failing to include microbial testing data during stability studies…
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