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.
- Changes to EU Medical Device Legislation: What you need to know - White Paper June 2016
- Clinical Data for Medical Devices - Preparing for increased requirements in the EU - White Paper, 2015
- Medical Device Overview
- Clinical Evaluation Reports - White Paper, 2015
- Wound Closure - White Paper, 2014
- EU Recast of the Medical Device Directives: The Rocky Road to the new Medical Device Regulation - White Paper, 2014
- Language Requirements for EU Medical Device Labels - Multilingual, September 2012