Premier Consulting Blogs

  1. 5 Steps To Planning And Executing IND-Enabling Nonclinical Studies 7/19/2023

    In this checklist, authors outline five steps for planning and executing scientifically rigorous, compliant IND-enabling nonclinical studies to help move development programs forward.

  2. Product Expertise And Market Knowledge Secures Fast-Track Review 4/27/2023

    Unearth how an international company was able to realize the full potential of its product by combining product expertise with target market knowledge to create a winning strategy.

  3. Developing Digital Medicines And Therapeutics: 5 Steps For Success 4/17/2023

    Download this checklist to access five key steps for ensuring regulatory requirements and commercial goals are built into a cohesive go-to-market strategy that addresses barriers and drives adoption.

  4. The Dynamic Landscape Of Digital Medicines And Therapeutics 4/17/2023

    Driven by advances in technology and increased acceptance of telehealth, uncover how digital medicines and DTx are poised to become an integral part of the healthcare model.

  5. In Silico In Action: A Case Study In Relapsing Remitting Multiple Sclerosis 4/17/2023

    Discover how in silico recreation can be a valuable tool for predicting the efficacy of new treatments.

  6. IVDR Survival Guide: Navigating Product Classification & Compliance Expectations 4/17/2023

    Address common questions concerning the IVDR product classification system and how to comply with the new clinical evidence and performance expectations.

  7. A Guide To In Silico Modeling And Simulation 3/30/2023

    Discover how in silico trials meet ethical codes and can be used to evaluate drug candidates.

  8. Using 505(B)(2) To Streamline Approval Of Combination Products 2/2/2023

    In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.

  9. 505(b)(2) Success In Oncology Combination Product Treatment 1/31/2023

    Discover why it is necessary to have the right regulatory and commercial plan in place early on based on sound science and medical, regulatory, and commercial assessments.

  10. Improving NDA Approval Odds For New Dosage Forms Of Approved Products 1/31/2023

    Learn why providing a more convenient and/or faster-acting dosage form of a well-chosen drug provides significant benefits for patients.