Orbis Clinical provides strategic and operational support to manage regulatory projects and initiatives. Our consultants are industry professionals who have the experience to manage entire portfolios, including pharmacy, devices, generics, over-the-counter, nutritionals and cosmetics.
Global Regulatory Strategy
Development & Implementation of Pre-IND/NDA, Clinical and Post-Market
Subject Matter Expertise
Regulatory Response, Rare Disease, Fast-Track, Orphan Drug, Rx-to-OTC switch
Operations & Submissions
-eCTD/CTD formatting and publishing
-Document management, archiving
-Global Dossier and Technical File review
-Writing/review/approval of label content
-CCDS development and review
Advertising & Promotions
-Product launch expertise
Submissions (NDA, BLA, IB, IND, CSR, MAA, 510k, PADER, DSUR etc.)
Non-Clinical/Clinical (posters, abstracts, slide decks)
To learn more about our services, contact us today!