What We Do
Quality & Regulatory
Quality and regulatory compliance is built into our business at every level and we embrace the importance of both throughout the manufacturing process from product development to the finished product.
- Batch Record and Vendor Management
- Annual Product Reviews (APRs)
- GMP certification
- Quality based on FDA regulations
- Audits by FDA, Health Organizations and Customers to enhance continuous improvement
- Process, Packaging and Cleaning Validations
- Testing and Release of Finished Goods and Incoming Materials
- Quality Reviews, stability studies and development of testing methods
- Health & Safety Environment and Continuous Improvement
- HPLC and GC Analysis
- Moisture & pH determination
- Identification of ingredients through FTIR
- Structured Product Labeling and NDC Submissions
- Stability Services
- Accelerated
- Concurrent
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