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
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eCTD/CTD formatting and publishing
-Document management, archiving
-Global Dossier and Technical File review

Labeling
-Writing/review/approval of label content
-CCDS development and review

Advertising & Promotions
-Promotional Review
-Product launch expertise

Medical Writing
Submissions (NDA, BLA, IB, IND, CSR, MAA, 510k, PADER, DSUR etc.)
Non-Clinical/Clinical (posters, abstracts, slide decks)

CMC
Strategy/Operations/Writing

To learn more about our services, contact us today!