The FDA is comprised of multi-disciplinary experts in chemistry, microbiology, pharmacology, toxicology and other various disciplinaries. It is important to keep in mind that these are the experts that will review your pharmaceutical product development report and data. A key to an effective strategy for IND planning is to know the process for submission. The…
In 2018, the FDA pledged to improve the drug approval process and the efficiency of drug development, allowing pharmaceutical development consulting firms to serve their clients more effectively. In attempt to prevent drug shortages and to increase generic drug access, the FDA is improving their drug review process. Pharmaceutical development services can be expedited due…
A trend of outsourcing regulatory affairs services has increased considerably. A lack of talented regulatory affairs professionals and stringent FDA regulations has contributed to the rising need for experienced FDA regulatory consultants. Pharmaceutical and device developers are focusing their energy in research and development operations while partnering with FDA regulatory consultants to provide regulatory affairs…