We help you rise to the top and achieve your goals
Electronic Submissions including INDs, NDAs, ANDAs, BLAs, IMPDs, CTAs, MAAs, Variations, Amendments and Supplements
Our team has filed countless fully-compliant electronic submissions of all levels of complexity with 100% success rate. We have a specific DNA which provides our clients with friendly service and an ability to meet tight timelines while delivering a high quality product. We look forward to collaborating on your next project.
Document Formatting and Publishing
We work with clients to publish big and small documents so they are compliant with guidelines and ready for submission to Regulatory bodies including FDA, EMA, Health Canada, PMDA, and Ethics Committees. We consistently deliver high quality, compliant documents.
Regulatory Information Management (RIM)
RIM allows you to consolidate all of your Regulatory information in one comprehensive resource which allows rapid navigation to Health Authority Requests, Submission Documents, Registration Dossiers and Regulatory Activities.