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

Great team to work with. Orbis team cares about the need of the employees every step of the way not just at the start.

Archana M.

Google

Myles was my recruiter contact Orbis and he was great ever since he brought this opportunity. He was well informed of the role and exlplained and understood how my experience pertains to the role. He was very responsive and always ready to answer any questions I had.

Clinical Study Specialist

Glassdoor

Professional, Friendly, Supportive, Consistent, Responsive, Follows up and doesn’t leaving you hanging!

Manager, Quality Management

Glassdoor

Contact Us

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