Regulatory: Pharma
CMC, Non-Clinical, Clinical, and PK Program Support
Our services: program support
As part of our regulatory services in pharma, the Alira Health team can:
- Assess the pre-clinical study requirements per the indication
- Review and analyze the drug product development and advise on formulation development, analytical testing, and validations per FDA requirements
- Develop the clinical study plan and design of clinical studies from Phase I through Phase III
Why choose Alira Health?
As your partner, Alira Health supports your innovation, optimizing product development success every step of the way. Our integrated, collaborative teams provide a lifecycle approach to delivering our services, including:
- Regulatory strategy
- Regulatory intelligence
- Regulatory operations
- Clinical
- Market access