We will work with you in both pre- and post-marketing drug safety regulations, regulatory filings, marketing authorization applications, variations and renewals, and assist in carefully developing due diligence strategies. Our regulatory experts manage the entire registration process for new drugs, biologics, generic products, and medical devices.
The FDA Group prepares all major regulatory submissions and provides extensive quality control review for all trial-related documentation, such as:
Our regulatory affairs specialists coordinate all aspects of your trial’s document collection and submissions, including:
Our team of experienced regulatory scientists can write the nonclinical, clinical, and Chemistry, Manufacturing, and Controls (CMC) sections in Common Technical Document (CTD) and traditional format for your new drug and biologic applications.
The FDA Group’s experience encompasses FDA clinical trial applications and registrations of medical devices, new chemical and biological entities, as well as those products containing established pharmaceutical ingredients (generics and 505(b)(2) products). We develop high-level regulatory strategies to expedite products through clinical trials and into the market, and regularly represent our clients in meetings with the FDA.
Our white paper offers a helpful look into effective CAPA and root cause analysis in FDA-regulated industries.