Our regulatory specialists excel not only in regulatory document preparation and project management but also in facilitating health authority engagement. We ensure comprehensive support throughout the regulatory process. This includes expert advice tailored to optimize product development and lifecycle maintenance.
ClinChoice’s regulatory team offers comprehensive support across various stages of clinical development and regulatory processes.
In the US, our regulatory specialists collaborate with clients to streamline product entry, ensuring compliance with FDA regulations for new products and successful completion of applications for approvals.
ClinChoice diligently detects and monitors changes, keeping a vigilant eye on regulatory developments. This proactive approach provides clients with timely communication, keeping them abreast of the latest regulatory updates. The team’s effectiveness is amplified by a comprehensive regulatory database, ensuring information is current and easily accessible. We provide expert guidance and advice in the following areas:
ClinChoice delivers extensive assistance for clinical projects through its Clinical Studies Submissions Database (CSSD), which encompasses study requirements and procedures for products. Our regulatory intelligence professionals guarantee compliance with regional and local requirements by accessing, summarizing, and assessing global regulatory intelligence. Additionally, we consult on country-specific legislation, establish liaisons with authorities and committees, and tailor regulatory training to ensure a holistic approach to regulatory compliance.