We are a team of professionals with excellent knowledge of Drug Regulatory Operations business gained from many years experience in the global pharmaceutical industry. Based on our practical experience we know about the special needs, challenges and potential pitfalls life-science industry faces when it comes to implementing and managing electronic submissions (interview with BioPro).
Over the last 11 years we developed, guided and performed regulatory business including, but not being limited to:
- Many successful eCTD submissions including lifecycle management for European CP, MRP, DCP application procedures and US NDA submissions
- Authority meetings with the EMEA, the FDA and national regulatory agencies such as the MHRA in UK or the TPD in Canada
- Implementation of the EU Clinical Trial Directive. Extensive experience with European clinical trial applications
- Implementation, validation and deployment of global document and submission management technology and business processes
- Training on eCTD and document authoring. Definition of style guides, document templates and standard operating procedures