The client was an India-based pharmaceutical company specializing in developing and manufacturing generic and innovator drugs. It was looking for Regulatory support in labeling and artwork for an ANDA. The project presented challenges such as the creation and review of ANDA labeling documents per the USFDA regulations and stringent timelines. Freyr deployed a team of experts who developed the required labeling components and worked on the artwork annotations. Freyr was able to help the client meet the timelines and their specific compliance objectives.
Decode how Freyr was able to offer Regulatory support to the client in labeling and artwork for an ANDA to the FDA, while overcoming multiple challenges. Download the proven case.