Newsletter | May 6, 2024

05.06.24 -- Long Live Design Controls: Navigating The Shift From QSR To QMSR

FEATURED EDITORIAL

Long Live Design Controls: Navigating The Shift From QSR To QMSR

The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.

INDUSTRY INSIGHTS

Switching From Vials To PFS And IV To Subcutaneous Formulations

Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.

Testing For Parenteral Packaging And Delivery Systems

There are many aspects to consider when developing a sound approach to performance testing to qualify packaging and delivery systems, as well as combination products.

Ophthalmic Drug Delivery

Explore the challenges to effective delivery of drugs to the eye, the intricacies of ophthalmic delivery, and the advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.

10 Ways To Align Your Medical Device With Human Factors

Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.

Emerging Trends And Opportunities In Orally Inhaled Drug Products

From targeting niche diseases to delivering cutting-edge medications, inhaled therapies are poised to become a cornerstone of modern medicine. Explore the intricacies of inhaled drug delivery.

SOLUTIONS

Real World Dosing Solutions For Patients

A Technology-Driven CDMO Delivering End-To-End Drug Delivery Services

Highly Flexible And Customizable On-Body Delivery System Platform