Drug Regulatory Affairs
Drug Regulatory Affairs
The key to fast regulatory approvals for clinical trials is based on understanding the ever-changing global and local regulatory landscape, combined with ongoing professional relationships with regulatory personals in each country.
Mediclin Clinical Research Drug Regulatory Affairs has both. Our regulatory team is constantly monitoring the regulatory environment of the global pharmaceutical and biotechnology industries, keeping track of changes in all local legislation, guidelines and regulations.
Mediclin Clinical Research 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 the 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 Drug Regulatory Affairs authorities and ethics committees, coordinating translations, and negotiating contracts with sites.