US Regulatory Services
By partnering with the Mapi US regulatory services team, you will leverage our many years of experience working with FDA to navigate and expedite your company’s US regulatory affairs capabilities
Our senior US consultants bring more than 30 years of experience working across a broad range of therapeutic areas. We have completed pre-IND, end-of-phase 2, pre-NDA and NDA negotiation meetings with the FDA as well as advisory committee meetings. We have experience in filing INDs, NDAs, and BLAs, as well as strategically managing the regulatory aspect of development projects from initiation through to the negotiation for approval. We also provide marketed product support / lifecycle management and critical issue management.
The Mapi US regulatory services team works with a diverse range of clients to provide US regulatory assessments, guidance and leadership to discovery, development, and mature product teams. We offer our scalable project models to meet client needs within budget.
Our capabilities include a broad range of regulatory services:
- Strategic regulatory consulting
- IND prep & Pre-IND to Pre-NDA
- NDA, BLA & ANDA preparations and filing, including CMC
- Post-approval support
- Agency liaison & negotiation
- Orphan drug designation applications & annual support
- Lifecycle management
- Review of promotional material
- US Agent services
- Full electronic publishing and submission services
In addition to our regulatory service offerings, we provide complete strategic product development consulting, including both tactical and strategic development plans, development risk assessment and outsourcing. This includes due diligence and evaluation of both in-licensing and out-licensing.