INHALATION DRUG DELIVERY ARTICLES

25_DDL_Regulatory_Reconnaissance_logo_color GenAI: The Muscle Behind Strong Regulatory Intelligence For Combination Products

In this article, combination product consultant Doug Mead provides the rationale and offers guidance for using GenAI tools to search regulatory databases. He shows the benefits for biopharma developers of conducting “precedent research” into previous regulatory pathways and results for similar or related drug delivery product submissions. 

INHALATION DRUG DELIVERY VIDEOS

In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks the panel to comment on regulatory challenges and considerations for traditional drug product pharma companies moving into combination product development. Patient centricity, device expertise, and supplier relationships are among the topics identified.

Examine challenges and key considerations for spray-dried formulations for inhalation, along with a review of current technologies and approved products utilizing particle engineering approaches.

In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks the panel to comment on regulatory movements of note. From his combination products and global operations leadership roles at FDA and now as regulatory consultant, panelist Barr Weiner points to global harmonization of regulatory definitions and requirements. Panelists Rumi Young and Fran DeGrazio weigh in on stability testing and specific ICH, ISO, and AAMI standards.

In this initial episode of The Combination Products Handbook: The Series, a chapter-by chapter videocast series introducing topics from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023), host Tom von Gunden discusses the book’s intent with its editor, Susan Neadle. The discussion focuses on the rationale for each chapter and the expert contributions of various chapter authors and co-authors.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

  • By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.

  • Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.

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  • Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.

  • Our integrated capabilities and vast knowledge encompasses pre-formulation sciences, formulation development, device evaluation, clinical trial manufacturing and the clinical assessment of a variety of inhaled formats for nasal and pulmonary delivery.

  • How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.

  • OFM automatic filling and closing machines are designed for pharmaceutical formulations, such as syrups, ophthalmic products, and nasal sprays either in glass or plastic containers.

  • Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."

  • Weiler Engineering’s ASEP-TECH® Blow/Fill/Seal machines are ideal for processing temperature sensitive products such as biological and protein-based materials – providing a level of enhanced sterility assurance.

  • This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.