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Small Molecule Services

CMC, Analytical

Quality, Timeliness and Cost Effectiveness

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Primera Analytical Solutions offers a broad scope of services that will assist your organization in completing the analytical work that is necessary for your FDA filing. We utilize state-of-the-art instrumentation to help you from early product development to commercialization of your product. 

We realize that hiring a contract lab is an important decision in your development process. Our team will work closely with you to ensure that we understand your timelines and we will provide honest feedback with regard to our capacity. Data quality and integrity are other critical aspects that you can entrust us with. As with any trusted partnership, we will work diligently to keep your studies in-budget and employ cost savings in our analytical approach.

Over 60 HPLCs
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Our Team

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When describing the Primera Small Molecule Team to our clients, the first words that come to mind are dedication, experience, and knowledge. We utilize weekly and bi-weekly meetings in addition to calls and emails for communication. Our dedication to communication and quality will ensure regulatory compliance and seamless results with the FDA for data generated by Primera.

The Small Molecule Team specializes in method feasibility, optimization, development, validation, method transfer and sample analysis. Our strong scientific expertise in cutting edge instrumentation, industry experience, and current regulatory compliance allow them to guide you from development to commercialization. Our highly skilled scientists have a proven record working with the most challenging compounds and complex products while providing fast turnaround times in both GMP/GLP and non-GMP/GLP environments.

Primera can handle nearly all drug substances and products. We have a high containment/high potency suite that can handle materials with an OEL at or below 10 ug/m3. In addition, we have DEA registration from Schedules I through V.

CMC, Analytical Broad Scope of Services

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  • Method Development and Validation
  • Method Optimizations and Method Transfers
  • Release and Stability Testing
  • Predictive Accelerated Stability Testing
  • Extractable and Leachable Studies
  • Nitrosamines
  • Genotoxic Impurities (GTIs)
  • Drug Substance Impurity Profiles
  • Residual Solvents
  • Coulometric and Volumetric Karl Fisher Testing
  • Elemental Impurities
  • Polymorph Analysis by XRPD
  • Particle Size Determination
  • Counter Ion Analysis
  • Discriminatory Dissolution Studies
  • Solubility Studies
  • Shipping Studies
  • Rheometer Studies
  • Capillary Electrophoresis
  • Cleaning Validations
  • Raw Material Testing
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Why Choose the Primera Team?

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  • There are many analytical CRO’s in our industry. What should your selection criteria incorporate? Here are some criteria that Primera has proven to be exceptional with:
    • Strong history of delivering regulatory compliant testing to include phase appropriate method qualifications and testing
    • Exceptional scientific knowledge of many complex products such as extended release formulations, solid oral dose, complex drugs to include medical devices, transdermal patches, buccal films, and injectables.
    • Primera team’s dedication to meeting timelines and strategic analytical goals
    • Staff of greater than 130 employees of which 20% have Ph.Ds
    • Successful completion of analytical work for INDs, NDAs and ANDA’s
    • Successful audit record with the FDA to include general inspections and pre-approval inspections (PAIs)
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