Early in Development
Consultation with PROMETRIKA’s regulatory experts early in the product development life cycle is key to the efficient and successful clinical programs, health authority submissions, and subsequent approvals. For sponsors in the pre-clinical stage, we can guide the manufacturing and non-clinical activities to assure that they adequately support the clinical program.
As you prepare to enter the clinic, the PROMETRIKA team lead by our regulatory strategists can assist in the you with clinical development plans, health authority meetings, submissions and continued support throughout the product lifecycle.
During the Clinical Phase
During clinical development, PROMETRIKA regulatory strategists can assist you with the planning of your interactions with health authorities including Pre-IND, End of Phase 2, pre-NDA, scientific advice and other health authority meetings. These activities can include the identification of major issues for discussion, preparation of the briefing package, meeting preparation and organization as well as preparation of the minutes and follow-up activities.
Experience
PROMETRIKA’s regulatory affairs team has experience with drugs, biologics and devices across a wide range of therapeutic areas in the US and the EU. We can assist you in generating development programs that simultaneously meet the needs of both regions.
Expedited Development Pathways
PROMETRIKA’s regulatory affairs team can guide our sponsors in determining if any of these pathways are suitable for their product development:
US Pathways
- Initial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meetings
- Fast-Tract Designation
- Breakthrough Therapy Designation
- Priority Review
- Accelerated Approval
EU Pathways
- PRIME: priority medicines
- Conditional Approval
- Approval under Exceptional Circumstances
- Accelerated Assessment