Primera Analytical Solutions is a GLP and GMP CRO in great standing with the FDA. Our primary objectives are quality and to become a trusted partner. 

Services include:

- Large and small molecule CMC, bioanalytical, release testing. Method development/validation, method transfer (Assay, Impurities, Dissolution, PK/PD, ADA, cell-based/non cell-based NAb)
- Cell & Gene Therapy (FACS, qPCR, ddPCR, cell-based assays
- Cell potency assays
- Impurity studies (LC/MS/MS, GC/MS, ICP/MS)
- Extractable and leachable studies
- Stability studies
- Dissolution
- Abuse-deterrent studies
- Solid state characterization
- Product and raw material release testing
- Metabolite characterization, bioavailability and bioequivalence studies
- Bioassay method development and validation
- Impurities by ELISA
- Peptide mapping
- HRMS

Analytics

Biotechnology

Clinical Trials

Health Care

Health Diagnostics

Life Sciences

Primera Analytical Solutions Corporation

Primera Analytical Solutions Corporation's headquarters in Princeton, NJ, United States

Bibo Xu

Steve Grossman

Bianca Buckwalter

Ingrid Wang

This department focuses on enhancing leadership capabilities and fostering growth within the organization.

Leadership Development

The Leadership Team at Primera Analytical Solutions Corporation guides the strategic vision and operational excellence of the company, ensuring alignment with regulatory standards and industry best practices. This team, comprised of senior executives with expertise in business development, IT, quality assurance, and corporate leadership, fosters innovation and collaboration to enhance service delivery and build trusted partnerships within the pharmaceutical and biotechnology sectors. Their focus on quality and compliance underpins all organizational initiatives, driving continuous improvement and client satisfaction.

Leadership Team

The Scientific Research Team at Primera Analytical Solutions is dedicated to advancing drug development through comprehensive analytical services. Leveraging expertise in method development, validation, and transfer, the team conducts a wide array of studies, including potency assays, impurity characterization, and stability testing. They ensure compliance with GLP and GMP standards, aiming to provide high-quality data that supports regulatory submissions and helps foster valuable partnerships with clients.

Scientific Research Team

The Quality Assurance team at Primera Analytical Solutions Corporation is responsible for ensuring the highest standards of compliance and quality across all analytical services offered. This team conducts thorough reviews and audits of processes, methods, and results to meet GLP and GMP regulations, while also serving as a trusted partner in the development and validation of methodologies. Their objective is to verify that all products and testing meet regulatory requirements and industry best practices, thereby safeguarding the integrity of data and fostering client confidence.

Primera Analytical Solutions Corporation

Org chart

Teams

Leadership Development

Leadership Team

Scientific Research Team

Quality Assurance

Offices

Primera Analytical Solutions Corporation

Org chart

Teams

Leadership Development

Leadership Team

Scientific Research Team

Quality Assurance

Offices

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