Tag: consulting

Accelerate Product Approval Using In Silico Modeling & Simulation

In clinical research and development, comparison to a control is highly recommended by regulatory agencies for the purpose of demonstrating evidence of clinical efficacy of a drug or device. The control could be a placebo, a known standard-of-care or an available market-approved drug or device. With some diseases or certain classes of devices, a viable...

Premier Research Launches Premier Consulting Business Unit, Creating Unified Regulatory and Strategic Product Development Brand

Morrisville, N.C., February 22, 2022 — Premier Research launched Premier Consulting today by consolidating two legacy brands within its portfolio — Regulatory Professionals, Inc. (RPI) and Camargo Pharmaceutical Services. Premier Consulting is a unified strategic product development and global regulatory consulting brand positioned for market leadership in support of emerging biotech and specialty pharma companies. The new...

Consulting

UPDATE – Draft FDA Guidance Concerning Combination Products

As those working in the development of combination products likely know, the Food and Drug Administration (FDA) issued two new draft guidances in December 2019. The guidances – Requesting FDA Feedback on Combination Products and Bridging for Drug-Device and Biologic-Device Combination Products– were published in response to the 21st Century Cures Act and Prescription Drug...