An efficient drug development process and rapid review and approval are the goals of every pharmaceutical sponsor, but numerous factors make this goal difficult and sometimes impossible to achieve. Although some of these factors are beyond the control of the sponsor, many delays in the regulatory process can be avoided by conceiving a robust regulatory strategy early in the development process. When a regulatory strategy document is prepared prior to development planning and updated throughout the development process, it provides the project team with a valuable reference resource and guideline, enabling them to make informed decisions in line with FDA requirements. This will ultimately reduce avoidable delays in the development, review, and approval processes and allow for the marketing of important new drugs.

We have demonstrated with many of our clients that a modern, state-of-the-art integrated drug development approach, using quantitative methods to inform, guide, and supplant traditional development methods, dramatically improves efficiency and reduces costs. Our team of experts work as an integrated part of your team, asking and answering questions, leveraging the most innovative modeling and simulation technologies and providing deep scientific and regulatory acumen to impact the Return of Investment of the clients R&D investment.

Chemistry, Manufacturing, and Controls Regulatory Affairs (CMC RA) maintains a central role in the development, licensing, manufacture, and marketing of pharmaceutical products. As part of this vital role, experienced CMC RA professionals assist in ensuring pharmaceutical products maintain consistent levels of effectiveness, safety, and quality for consumers. Expansions in technical experiences and scientific knowledge have led to advanced biopharmaceutical manufacturing processes and products. This increased complexity has resulted in a growing and evolving array of regulatory agency expectations related to CMC activities. It is essential that sponsor companies fully comprehend regulatory compliance requirements for their specific type of pharmaceutical product, and they devote sufficient resources needed to meet these requirements. Overall, CMC RA plays a pivotal role in the development, licensure, manufacturing, and ongoing marketing of pharmaceutical products. In this role, CMC RA professionals help ensure that pharmaceutical products are consistently effective, safe, and provide high quality for consumers

We have a team of CMC professionals who have experience in both authoring and submitting. Our team members have many years of experience in submitting, as these individuals are responsible for preparing scientific responses to regulatory agency queries, which is significant in determining whether the drug is approved.