The key to fast regulatory approvals for clinical trials is based on understanding the ever-changing global and local regulatory landscape, combined with on-going professional relationships with regulatory personnel in each country.
CROMSOURCE has both. Our regulatory team is constantly monitoring the regulatory environment of the global medical device and biotechnology industries, keeping track of changes in all local legislation, guidelines and regulations.
CROMSOURCE’s Regulatory team consists of local staff with a deep understanding of that country’s regulatory requirements. Our staff will work alone or in-concert with a sponsor’s Regulatory team. Together we will develop the strategic regulatory plan for the study, identify the best countries to be involved, and assist the sponsor in working with regulatory authorities and ethics committees, coordinating translations, and negotiating contracts with sites.