Solves mission critical challenges and bring life-changing therapies to patients faster with Advarra Consulting Our team of expert consultants, organized in Centers of Excellence specializing in Quality, Regulatory, Clinical, and Institutional Research, are experienced industry practitioners—alumni from some of the most respected companies in the world—offering their extensive hands-on experience to provide outcome-oriented solutions across the product development lifecycle.

Advarra can support the following CMC areas:
- CMC strategy to ensure fit-for-purpose operations.
- CMC evaluation / gap assessment to help develop an effective implementation roadmap.
- Support for FDA meetings, obtaining guidance to help ensure regulatory success.
- Establish “fit-for-purpose” QMS to ensure compliance at the right price.
- Seamless integration with clinical supply activities to reduce trial delays.
- Validation and qualification of pharmaceutical development processes in line with QMS & CMC strategy.
- Pre-approval Inspection (PAI) Readiness.
- End-to-end design and implementation of required organization and processes.
- Vendor qualification audits and monitoring.
- Sponsor and vendor pre-inspection readiness.