In 2013, the government – as per 503B (d)(4)(A) of the FD&C Act – created 503B outsourcing facilities to compound sterile and non-sterile products and biologic agents. These facilities operate using the quality standards of 21 CFR 210 and 211.
503B facilities provide formulations and products that are not commercially available and assist with drug shortage supplies and repackaging. Biomed Innova’s strategic partnerships with these facilities will help build and sustain quality and regulatory programs, promote FDA support and minimize risks.
Services Offered
- Formulation Development
- Formulated products
- Product Validation Assays
- Chemistry Method Development and Validation
- Raw Material Testing
- In Process Testing
- Finished Product Lease
- ICH Stability Studies
- Impurities Characterization
- Solubility
- Dissolution
- Disintegration
- Raw Material and API Testing
- Regulatory and cGMP Support
- Drug Shortage Formulations
