Industry Insights

  1. A Brief History Of Parenteral Process Validation — How We Got Here 6/29/2020

    Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. This article will look at how process validation evolved to become the primary means of ensuring consistent, high-quality production of parenterals.

  2. EU MDR Postmarket Clinical Follow-Up Compliance: 3 Tips & 3 Pitfalls 9/13/2021

    The EU MDR regulation imposes new requirements for clinical evaluation for some Class III and implantable devices, narrowing equivalence routes and placing greater emphasis on postmarket clinical follow-up (PMCF). This article provides three best practices for compliance and then offers an overview of common issues observed in notified body submissions.

  3. Answer These 3 Questions Before Developing Software As A Medical Device 2/22/2021

    Whether your organization is interested in software adoption to build in continuous data acquisition, offer remote care capabilities, improve patient engagement, or simplify routine clinical tasks, software as a medical device (SaMD) is at the center of it. Before getting started on your SaMD project, answer these three questions.

  4. A Proven AAV Platform To Drive Down Program Costs And Maximize Speed

    To ensure that your adeno-associated virus (AAV) therapy reaches patients as soon as possible, begin your relationship with an experienced AAV manufacturer early in the development journey.

  5. The Need For AI/ML In Drug Discovery, Dev, & Clinical Trials 10/25/2021

    While an influx of new companies and technologies is spurring innovation in the industry, these startups are increasingly in competition for talent and capital. Although a fairly new area with respect to the use of AI, the drug design and development process is ripe for the application of machine learning and deep learning techniques. 

  6. Taste-Masking: A Unique Solution To Improve Patient Compliance 8/10/2021

    Taste plays an especially important role in pediatric medications, but it can affect adult compliance as well. No matter age, if you have poor-tasting medicine, you’re more likely not to take every dosage.

  7. The Missing Links For A Strong Quality Culture: Skill Definition & Assessment 5/4/2020

    To build and sustain a strong quality culture, the organization must understand the critical skills needed to assure all employees can act in the patient’s best interest when making decisions on product quality and usability. 

  8. FDA Remote "Inspections" During The Pandemic 3/24/2022

    Remote inspections can be easy if the company being audited has invested in a quality management system that stores its documents, provides version control, and tracks all changes.

  9. 7 Key Concepts In The FDA's Quality System Guidance For Pharma 3/4/2022

    Here are some key concepts that the FDA deems critical for a discussion on modern quality systems and defines them within the scope of pharma manufacturing.

  10. Factory/Site Acceptance Testing & Commissioning Responsibilities 2/22/2022

    Execution of factory acceptance testing (FAT) and site acceptance testing (SAT) is a business-critical activity when it comes to commissioning of a new system or equipment. FAT is conducted at the equipment manufacturer’s site and SAT is conducted at the final site of installation. This article shares best practices.