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Small Molecule Services

Development & Validation

Small Molecule Method Development and Method Validation Designed for You

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Depend on Primera to create streamline methods and conduct phase appropriate validations. We will work closely with your team to provide a robust method and a validation that works for its intended purpose.

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Top Pharma Companies Trust Primera's Extensive Expertise in Method Development and Validation

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When a method needs to be developed and validated, it is important to trust the firm you choose to conduct the work. Primera’s analytical method development and validation team is staffed with highly experienced professionals that complete projects with accuracy and cost effectiveness. 

Initially, a Primera team member will meet with your organization to determine the requirements of the development and validation.Since Primera is both a GLP and GMP laboratory, our laboratory can support you in all stages of pharmaceutical development from discovery to commercialization. Our goal is to ensure that the method we develop fully meets your requirements.

Our Team

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To work on Primera’s method development team, Primera requires experience, knowledge and a sense of creativity. A member of Primera’s validation team must have meticulous technique and dedication to quality.

Our team’s exceptional skills and proven record have allowed them to work on very challenging compounds and complex formulations. We have developed complex validation ready methods in timeframes that are truly remarkable.

As you are aware, communication is critical to success. We will work with you in the method development phase to ensure the method developed meets the intended purpose. As for the method validation stage, the Primera subject matter expert (SME) will provide a protocol that will be reviewed by your team to ensure all analytical criteria are met. Primera will also accept a client protocol for execution once it has been reviewed by our Quality Group.

Typically, Primera will schedule weekly or bi-weekly meetings with clients to discuss study progress, difficulties and data. Meetings are productive and ensure that all analytical strategies are met with changing client requirements.

Primera Analytical Services Small Molecule Development Validation

Our validation protocols typically include:

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  • Accuracy
  • Precision (Repeatability and Intermediate Precision)
  • Specificity
  • Detection Limit (Impurities)
  • Quantitation Limit (Impurities)
  • Linearity
  • Range
  • Sample and Standard Solution Stability
  • Robustness

Phase appropriate validation will include some of the above listed analytical tasks but not all. Typically, intermediate precision and robustness are eliminated for early stage method validations (qualifications). Comprehensive tasks such as accuracy may be also reduced for early stages.

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