THE RIGHT FIT
At Opus, we measure regulatory affairs consulting success with mutual client and consultant satisfaction.
We achieve this by leveraging our pool of super-star Regulatory Strategists, CMC , Labeling and Ad Promo experts for each project. We call this Regulatory Matchmaking.
Filling the gaps
The work does not stop while you search for your permanent, full-time employee.
Functional outsourcing
Providing a flexible and nimble approach to sourcing all or part of a department.
critical needs
We are ready to jump in to ensure business does not get interrupted when someone leaves unexpectedly.
our practice areas
Regulatory Strategy
Global Experience
- Early through late stage development
- Lifecycle management
- Clinical trial planning and protocol review
- Study start up consultation
Pathway Assessment
- Orphan Design
- Pediatric
- Fast Track
- Breakthrough therapy designation
- Priority review and accelerated approval
Health Authority Prep
- Pre-IND/CTA
- End of Phase 2
- Pre-NDA/BLA
- Late-Cycle meetings
- FDA Ad Comm
- US and ex-US
Functional Leadership
- Representing on cross-functional teams
- Regulatory intelligence
- Cutting edge knowledge of FDA guidelines
Regulatory CMC
CMC Strategy and Execution
- Developing CMC strategy
- Responsible for final content in CMC sections submitted to health authorities
- Working in collaboration with key functional areas: Product Supply, Clinical/Non-Clinical
Global and Local Experience
- Driving final content in CMC sections submitted to health authorities
- Working in collaboration with key functional areas: Product Supply, Clinical/Non-Clinical
Health Authority Interactions
- Lead interactions relative to CMC issues
- Pre-IND
- End of Phase 2
- Pre-NDA
- Late-Cycle Meetings
- FDA Ad Comm
Functional Leadership
- Representing CMC on cross-functional teams
- Regulatory intelligence, relative to CMC
- Cutting edge knowledge of FDA guidelines
- Proactive identification of issues, escalation to management as appropriate
Labeling
End-To-End Development
- Create and maintain core and regional labeling
- CCDS, USPI, EU SmPC
- Develop target labeling to support Phase 1 & 2
- Ensure compliance through quality checks and tracking mechanisms
- Draft labeling operating procedures and workflow
Leading Cross-Functionally
- Provide insight and strategy to arrive at team consensus
- Chair labeling committee meetings
- Ensure strategic alignment for products
Health Authority Engagement
- US and ex-US
- Manage initial filing
- Support Health Authority information requests
- Preparation of labeling for submission to HA’s and/or subsidiaries worldwide
Tailored Labeling Education
- Virtual or in-person sessions
- Tailored content for your team
- Core, US, EU, ROW, Target, Labeling Working Group Meetings, Labeling 101
- Sessions presented by Senior Level Consultants accustomed to conference presentations
Ad Promo
Cross-Functional Education
- Review and approval of all advertising and promotion materials
- Early engagement with concept development
- Branded, unbranded and disease awareness
- Strategic, risk based reviews
Process Development
- Procedure auditing
- SOP drafting and review
- Veeva implementing guidance
- Training and mentoring of new hires
Health Authority Engagement
- FDA Advisory Comments submission strategy and execution
- 2253
- Subpart H/E
Launch Planning
- Implementation plan
- Accelerated approval timeline
- Safety doc drafting
- Pre-approval communication guidance
client feedback
Opus is a well-organized and dedicated Regulatory affairs consulting company that not only provides great Regulatory support, but manages their projects and billing well. I have appreciated the experience level of their consultants and how integrated the consultants are with the project teams.
—Senior Director, Regulatory Affairs at a company developing de novo therapeutic proteins