lab services
Services for Commercial Products
Drug product approval is only the beginning. For production-stage drug products, Proveris Labs can help to ensure that your timelines are met and that product quality is maintained.
For example, we can evaluate production SOPs not only for system performance, but also for maintenance procedures, resulting in maximum operating time, more efficient training programs, and optimized equipment lifecycle planning.
You can also leverage Proveris’s expertise and knowledge to expedite evaluations such as OOS, OOT and CAPAs—so that they can be closed faster, in a data-driven manner.
Technology and Method Transfer
- Proven process to bridge methods across different sites and/or on different instrument generations to ensure proper functionality and reduce unexpected results
- Assistance with identifying any possible differences on the instruments, achieving seamless method transfer within a shorter time frame
Out-of-Specification (OOS) and CAPA Investigations
- Minimize production delays by reviewing and analyzing existing data, diagnosing possible root causes, and creating a concrete path to solutions
- Proveris Labs can also serve as an independent testing site for OOS samples, and provide valuable backup data needed to close CAPA investigations
Supply Chain Management
- Avoid unnecessary regulatory burdens by evaluating, and documenting, second sourcing and other key supply chain management initiatives
- Evaluate performance specifications of your product following any supply chain changes and provide recommendations on any method optimizations required
- Provide a comprehensive report summarizing the results as well as relevant scientific justifications that can be used as supporting data with regulatory agencies
Access current, relevant resources for respiratory drug development & quality control.
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From a Proveris Sales Associate