With expertise spanning across small molecules, large molecules, cell and gene therapy products, biomarkers, oligonucleotides, and everything in between, we navigate you from preclinical and clinical to post-marketing stages of drug development.

Supporting a Wide Range of Drug Modalities and Platforms

Drug /Molecule Type

• Small Molecule NCE
• Biologics
• Oligonucleotides
• Biomarkers
• Immunogenicity/ADA
• Neutralizing ADA
• Antibody Drug Conjugates (ADCs)
• Cell and Gene Therapy Products (CGTPs)

Assay/Platform Expertise

• LC-MS/MS
• HRMS
• LBA (ELISA, ECL, RIA, etc.)
• Molecular (qPCR, RT-qPCR, ddPCR, etc.)
• Cell-Based (Potency, ELISpot, FACS, etc.)

Stages of Development

• Discovery
• IND-Enabling/GLP Preclinical
• Clinical Phase I – IV
• BLA/NDA Support
• Post-Market Approval

Bioanalytical Regulatory Guidance and Submissions

In pharmaceutical development, regulatory guidance and industry best practices play a critical role in guiding all stages of discovery and development. Expertise matters even more when specific guidance is lacking. From strategic planning to submissions, our bioanalytical team of experts bring their extensive regulatory knowledge and experience to your bioanalytical programs.

We provide regulatory guidance related to:

• Fit for purpose method qualifications
• GXP bioanalytical method validations
• Bioanalytical tables/reports supporting FDA and EMA submissions
• Sample analysis and sample analysis reports
• Preparing for regulatory interactions and responding to feedback from regulatory agencies