The role of regulatory affairs professionals in the pharmaceutical industry is to ensure compliance with regulatory requirements and guidelines set by various regulatory authorities. ​ They play a crucial role in the development, approval, and post-marketing surveillance of pharmaceutical products. ​ Some specific responsibilities of regulatory affairs professionals include: ​ Regulatory Strategy Development They are…
The purpose of regulatory submission and review is to obtain approval from regulatory authorities for the marketing and sale of pharmaceutical products. ​ Regulatory submission refers to the process of preparing and submitting comprehensive documentation to regulatory authorities that provides evidence of the safety, efficacy, and quality of the product. ​ The regulatory review process…
Fixed-dose combination (FDC) drug products present unique challenges in biowaiver assessments, as they involve multiple active pharmaceutical ingredients (APIs) with different physicochemical properties and release characteristics. Regulatory guidelines (USFDA, EMA, WHO) provide biowaiver provisions, but their applicability depends on several factors, such as API solubility, permeability, formulation type, and release mechanisms. Key Considerations for Biowaivers…
Adjusting polymer content in a sustained-release dosage form requires a systematic approach to maintain the desired drug release profile while ensuring manufacturability and regulatory compliance. Role of the Polymer in Drug Release Control Polymers in sustained-release formulations act as matrix formers, coating agents, or swelling/erosion regulators. For example, HPMC, Ethylcellulose (EC), and Polyethylene Oxide (PEO)…
Regulatory compliance is a critical aspect of pharmaceutical product lifecycle management. When making post-approval changes in topical formulations, selecting the appropriate FDA submission pathway—CBE-30 (Changes Being Effected in 30 Days) or PAS (Prior Approval Supplement)—ensures compliance while maintaining business continuity. Understanding when to file CBE-30 vs. PAS can significantly impact timelines, regulatory approvals, and market…
Formulating effective topical products is a complex process that requires balancing efficacy, stability, and patient compliance. Here are some common challenges and practical solutions: Poor Drug Penetration Instability of Active Ingredients Phase Separation in Emulsions Grittiness or Texture Issues Preservative System Failure Inconsistent Spreadability & Feel Successful topical formulations require a deep understanding of formulation…
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