Global Regulatory Strategy
Development & Implementation of Pre-IND/NDA, 510K, PMA, Clinical and Post-Market, Liaison to Regulatory Agencies
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.
Learn MoreLife sciences regulatory affairs staffing expertise
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
What people are saying about Orbis Clinical
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.GoogleMyles 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.
Professional, Friendly, Supportive, Consistent, Responsive, Follows up and doesn’t leaving you hanging!
Ready to Strengthen Your Regulatory Team?
Talk to our team about your regulatory affairs staffing needs, or call us at (781) 328-1132.