Cromos Pharma has deep regulatory knowledge, experience and skills that provide an invaluable asset for clients wishing to conduct clinical research in a variety of jurisdictions. Our Regulatory Department operates in accordance with the relevant FDA and EMA Directives and national regulatory requirements across all countries of our geographical coverage.
We have comprehensive knowledge and experience with the applicable local regulatory documents, requirements and approval procedures for US, EMA, local European countries, including expertise in the procedures and activities required for the efficient import/export of APIs and medicines and a deep and localized knowledge of the relevant mechanisms for Regulatory Authorities (RA) and Ethics committee (EC) document submission. The company's duty is to deliver studies and all related clinical activities in accordance with Cromos Pharma's SOPs and Working Instructions, unless the client wishes for Cromos to operate under client SOPs.
Our team of high quality regulatory professionals provides regulatory support at all stages of clinical research, starting from the process of developing of the Study Protocol through to the Final Study Report.
Below is average timelines for study regulatory approval based on Cromos Pharma's experience in various countries.
Within the last 3 years more than 40 successful submissions for clinical trial authorizations in various countries of our operations have been completed by Cromos Pharma. In addition, 23 dossiers for initial marketing authorization and 19 submissions for changes to original dossiers have been executed since 2013.