Expertise: Consulting 225 results
The FDA’s Oncology Center of Excellence (OCE) plays a pivotal role in fostering innovation, collaboration, and efficiency in the development and evaluation of oncology products. Established in 2017 under the 21st Century Cures Act, the OCE brings together multidisciplinary scientific...
Clinical Development
RAPS San Francisco Bay Area Chapter In-person 2025 Kick-Off Meeting
New drug development is a long and expensive process that can be fraught with obstacles, including unexpected delays, poor efficacy results, safety issues, or regulatory challenges. Pharmaceutical companies may, at times, find themselves at an impasse during development, facing weighty...
Bringing a new therapeutic to market is a complex and multifaceted process culminating in submission and approval of a new drug application (NDA). Within the NDA, the chemistry, manufacturing, and controls (CMC) section plays a pivotal role in demonstrating drug...
Creating inhaled combination products (ICPs) demands precision at the intersection of drug formulation and device engineering. These products deliver multiple active pharmaceutical ingredients (APIs) via a single device, making Chemistry, Manufacturing, and Controls (CMC) critical to ensuring safety, efficacy, and...
Process validation is a critical regulatory requirement in pharmaceutical manufacturing. It ensures that a production process consistently yields products of predetermined quality and safety. The goal is to verify that all stages of drug production—from raw materials to final dosage...
For drug developers the 505(b)(2) pathway presents an expedited pathway to FDA approval. In our experience, the conversation on 505(b)(2) pathways commonly focuses on predicate data or bridging strategies to accelerate FDA approval but lacks dialogue on the needs of...
Inhaled combination products (ICP) have emerged as a significant advancement in the treatment of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary conditions. Inhalation offers a targeted route of drug delivery directly to the lungs,...