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)

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Labeling

• Writing/review/approval of label content

• CCDS development and review 

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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)

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CMC

• Strategy/Operations/Writing