Infinity Laboratories consulting team can help you get your new medical device or pharmaceutical products to market. We provide access to a strong, well connected team of research, development, and regulatory experts with direct industry experience. Serving as an extension of your team, Infinity Laboratories will help you design and as needed, execute evidence-based, regulatory-accepted strategies to increase product development success.
- Facility Validations (Water Systems, Environmental Monitoring, and Process Controls)
- Laboratory Training Programs
- Protocols, SOPs and Reports (Write SOP and execute IQ/OQ/PQ protocols for laboratory and production equipment)
- Biocompatibility and material characterization risk assessments (ISO 10993)
- Packaging Validations
- Product-specific validations and failure investigations
- Regulatory support for product changes