Analytical Expertise
for Unmatched Results

Development, validation, and testing with precision.

Analytical Development ensures every product meets the highest standards of quality, safety, and compliance. With QA oversight, our processes guarantee data integrity, method validation, and adherence to global regulatory requirements. With tailored solutions, cutting-edge technology, and a team of experts, we ensure precision and reliability in every method and result. From developing robust analytical methods to validating equipment and monitoring stability, QA is integrated at every step to ensure your product’s success.

Dedicated Excellence That Drives Success

Benuvia’s Analytical Development Services are more than a capability—they’re designed to be a cornerstone of our commitment to your success:

  • Dedicated Expertise for Every Project
  • Comprehensive Method Development & Validation
  • Integrated R&D and Quality Control
  • Specialized Analytical Testing
  • Stability Testing
  • Quality Assurance and Control

Dedicated Expertise
for Every Project

Every project benefits from a dedicated AD Chemist who provides personalized attention and expertise. From method development to validation, we ensure seamless management and precision at every stage, delivering results that align with your specific project needs and goals.

Comprehensive Method
Development & Validation

Our team develops and validates robust analytical methods tailored for APIs and drug products across multiple dosage forms. Whether it’s topical creams, oral capsules, injectables, or sublingual formulations, we ensure precision, accuracy, and regulatory compliance in every method.

Integrated R&D
and Quality Control

By aligning Analytical Development with R&D and Quality Control, we streamline workflows and enhance efficiency. This collaboration ensures accuracy from method creation through to final release, minimizing delays and maintaining high-quality standards throughout your project.

Specialized Analytical
Testing

Benuvia’s advanced analytical testing addresses key parameters such as assay, impurities, water content, and physical appearance. These capabilities ensure your product meets all necessary requirements for regulatory submissions, including DMFs, INDs, NDAs, and ANDAs, with confidence.

Stability
Testing

Our ICH-compliant stability chambers provide reliable data under diverse conditions, assessing product shelf-life and storage requirements. From standard testing to unique formulations, we deliver the insights needed to maintain product quality and regulatory compliance.

Quality Assurance
and Control

Benuvia combines QC testing with independent QA oversight to ensure compliance and product integrity. Precise instrumentation verifies product specifications, while our autonomous QA team reinforces reliability and safeguards processes from start to finish.

Benuvia's dedicated chemists, advanced testing capabilities, and tailored solutions ensured every aspect of our project met the highest standards. From method validation to stability testing, they provided precise, reliable results that accelerated our development timelines and simplified regulatory submissions.

Mid-Sized Pharmaceutical

Senior Director of Product Development

Specialized Expertise, Unrivaled Precision

Our dedicated team of AD Chemists, cutting-edge instrumentation, and deep expertise in niche products like cannabinoids, entheogens, and controlled substances, provide the precision you need to succeed:

  • Regulatory Confidence
  • Tailored Solutions for Complex Needs
  • Accelerated Development Timelines
  • Quality Assured
  • Streamlined Collaboration
  • Broad Expertise, Niche Precision
  • Scalability and Flexibility

Regulatory Confidence

Benuvia’s adherence to FDA, ICH, and global guidelines ensures your analytical data is reliable and compliant. From method validation to stability testing, we provide the precision and thoroughness needed to facilitate seamless regulatory submissions and secure global market access.

Tailored Pathways

Our specialized expertise in cannabinoids, entheogens, and complex formulations allows us to craft analytical solutions tailored to your product’s unique requirements. By addressing specific challenges and specifications, we ensure your project stays on track and exceeds expectations.

Accelerated Timelines

With dedicated AD Chemists and streamlined processes, Benuvia minimizes delays and accelerates your project’s progress. From method development to regulatory submission, we ensure each step is efficient, helping you meet milestones and launch timelines with confidence.

Quality Assured

QA ensures that all analytical methods developed and validated meet global standards for accuracy, precision, and reproducibility. By safeguarding data integrity and overseeing testing protocols, QA provides the foundation for reliable results that drive informed decisions throughout the drug development lifecycle.

Streamlined Collaboration

Our cross-functional team approach combines analytical development, R&D, and Quality Control to create a seamless workflow. This ensures open communication, aligned goals, and efficient project execution, delivering results that inspire trust and foster long-term partnerships.

Advanced Expertise

Benuvia’s team has extensive experience across analytes and dosage forms, including injectables, oral capsules, topical creams, and sublingual formulations. Our expertise ensures even the most specialized projects receive accurate, high-quality data tailored to your needs.

Scalability and Flexibility

From early development to commercialization, our analytical services adapt to your project’s evolving needs. Whether scaling for clinical trials or large-scale production, we provide consistent, reliable support at every stage to help you succeed in dynamic markets.

Discover how Benuvia’s Analytical Development Services have driven success for our clients with tailored solutions, expert collaboration, and advanced methodologies. Exceptional results delivered, from development to regulatory approval.

Speak with an Expert

Rebecca Soto

Analytical Development Manager

Rebecca is an experienced scientist with over 20 years of laboratory work in various fields ranging from clinical diagnostic laboratories to reference standard manufacturing and pharmaceutical quality testing. She received her undergraduate degree in Chemistry from Eastern New Mexico University and quickly developed a strong interest in instrumentation and analytical testing through her time with various high-volume laboratories. She has spent over 10 years performing laboratory testing at manufacturing sites like Hospira, Millipore Sigma and Benuvia with the majority of those years focused on analytical method development, transfer, and optimization. Rebecca brings a unique perspective to the Analytical Development group to ensure all project work is accurately performed to the highest quality standards.

Contact Me

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