Regulatory Affairs

Orbis Clinical can provide strategic and operational support to manage all biotech regulatory affairs projects and initiatives. Our consultants are industry professionals that have the experience to manage entire portfolios to include Rx, Devices, Generics, OTC, Nutritionals and Cosmetics.

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Find out how Orbis Clinical can help you

Talk to Our Business Development Team

Life sciences
regulatory affairs staffing expertise

Global Regulatory Strategy

Development & Implementation of Pre-IND/NDA, 510K, PMA, Clinical and Post-Market, Liaison to Regulatory Agencies

Labeling

Creating/Review/Approval of New Product Development (NPD) labels, writing/review/approval of post-marketed labels, CCDS development and review, labeling proofreading/artwork review and management. Excel in rebranding projects.

Subject Matter Expertise

Regulatory Response, Rare Disease, Fast Track, Orphan Drug, Rx to OTC switch, Medical Device, MDD to MDR, Liaison to Regulatory Agencies

Medical Writing/Advertising & Promotions

CSRs, Narratives, Submissions (Pre-IND, NDA, sNDA, BLA, sBLA), Non-clinical/clinical, promotional review, product launch expertise

Operations & Submissions

eCTD/CTD formatting and publishing, Pre-IND, NDA, sNDA, BLA, sBLA, Document management, archiving, Global Dossier and Technical File review

CMC

Strategy/operations/writing

Very responsive, quality candidates, and great to work with.

Client

ClearlyRated

I love working with Orbis; they understand the requirements for the role very well and thoroughly vets the candidate before sending their CV. Thanks for going an extra mile and checking in on the candidate's performance once hired.

Client

ClearlyRated

My recruiter was great at finding me placements and guiding me through my career at Orbis.

Former Contractor

Glassdoor

Contact Us

Fill out the form below to get in touch with our business development team, or call us at (781) 328-1132.