Biopharmaceutical Pharmaceutical Drug Product Stability Consulting Service
Our Stabilityshire℠ expertise and analysis capabilities provide a very cost-effective way for organizations to maximize the benefit from their stability program. Our Stabilityshire service, led by our Chief Stability Scientist, provides a full range of services for intermediates, API, drug substance, and drug product stability and shelf-life data consulting, analysis, and reporting, stability study design, CRO selection and management, regulatory assistance and filings, including CMC writing. Our quality system is built around ISO and cGMP compliance. Stabilityshire allows organizations to supplement internal capabilities, as needed, or to completely outsource their stability data management, analysis and reporting requirements, while accessing expert consulting assistance.
The main reason for stability testing is to ensure the patient’s safety and product quality through establishing the shelf life (expiration dating period) of pharmaceutical products and their precursors, API, drug substance and intermediates. Stability testing evaluates the effect of environmental factors on quality. This data is used to predict shelf life, determine storage conditions, appropriate primary and secondary containers and guide labeling instructions. Also, data generated from stability testing is a requirement for IND studies and regulatory product approval. Because stability testing involves: i) considerable resources and cost; ii) extends for long periods of time; iii) consumes considerable resources; and iv) gets significant regulatory scrutiny and is important in regulatory filings, it is imperative that these studies be performed right the first time and efficiently.
Many organizations have suffered from poorly designed stability studies and mismanagement of stability data. This can lead to regulatory questions, observations and delays, suboptimal supply chains, lost product inventory, stock-outs and the need to repeat studies. Don’t let this happen to you!
See our video on Stabilityshire℠ and client testimonial below.
The Stabilityshire℠ service capabilities include:
- Fully validated statistical analysis software that is compliant with cGMP, Part 11 and ICH Q1E
- Management and monitoring of entire programs
- Expert consulting, reports and recommendations
- Regulatory advice and submission support
- Assessment and audits of stability programs
- A fully compliant cGMP quality system
- Standard audit ready stability reports
- Deviation and investigation support
- CRO selections and oversight
- Data and trend monitoring
- Shelf-life determinations
“I have been using Stabilityshire℠ for consulting advice for the last year. They have consistently delivered results that are catered to my specific needs. Their reports are accurate, dependable, and easy to follow. Their customer service is excellent, as requests, even general questions, are always followed up on directly and always in a timely manner” – Principal Scientist, Orphan Drug Development Company