Regulatory Affairs
Navigate complex regulatory challenges with expert support
Expertise
Regulatory Submissions & Resourcing
- Review of client technical dossiers and developmental plans
- Research and interpretation of regulations
- Determination of regulatory status
- Pre-submission review of technical documents
- Critical writing and review of documentation
- Clinical trial applications and notifications (IND, IDE, CTX, etc.)
- Marketing Application Support (NDA, BLA, ANDA, 510(k), PMA, etc.)
- Orphan Drug, Treatment Use, and ANDA Suitability petitions
How We Work
Engagement Models
Consulting Projects
Put your projects in the hands of qualified third-party experts.
Staff Augmentation
Get contracted full-time consultant (FTC) staffing support and functional outsourcing.
FTE Recruitment
We rapidly identify and place direct hire candidates in a variety of positions.
Step by Step
Our Proven Process
1Introductory Conversation
2Resources Definition
3Proprietary Resource Selection Process
4Resource Presentation
5Agreement Processing
6Account Management