Product Development
CMC Project Integration
Project support designed around your goals
We deliver the full spectrum of project integration support, all designed around your business needs and goals. We’ll work closely with you to:
- Coordinate the activities of an integrated CMC team
- Develop timelines and budgets for global regulatory dossiers
- Coordinate the activities of the sponsors, vendors, and consultants as subject matter experts
Why choose Alira Health?
Our team of subject matter experts support the design and development of robust, scalable manufacturing processes. They provide:
- Coordinated, adept facilitation between clients and CDMOs
- Experienced project management with a focus on timelines and budget for multidisciplinary CMC teams, including clients and vendors
- Deep background in coordinating authors to create regulatory documentation for submission in line with critical timelines
- Tailored guidance on preparation of pre-IND, IND, IMPD and BLA filings