We provide 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, nutriceuticals 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)

Labeling

  • Writing/review/approval of label content

  • CCDS development and review 

Advertising & Promotion

  • 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

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(781) 328-1132

100 Unicorn Drive #2 

Woburn, MA 01801

© 2020 by Orbis Clinical