Resolian


Global contract research organization providing bioanalytical, analytical sciences, and supporting laboratory services across preclinical and clinical drug development. Offers method development and validation, DMPK support, ultra-trace impurity analysis, materials characterization, forensic particulate analysis, and sample management via a harmonized multi-site network (US, UK, China, Australia) with GxP-compliant quality systems.

Industries

biotechnology
pharmaceutical

Nr. of Employees

large (251-1000)

Resolian

Malvern, Pennsylvania, United States, North America


Products

Biomarker assay list (downloadable)

Comprehensive list of available biomarker assays and methods; additional methods can be developed on request.

Scientific posters and methodological resources (downloadable)

Technical posters and case study resources on topics such as nitrosamine testing, green E&L methods, SFC methods and peptide permeability assay optimisation.


Services

Comprehensive bioanalysis including PK/PD/TK, immunogenicity, biomarker quantification and method transfer across global sites.

CMC testing, impurity identification, extractables & leachables profiling, elemental analysis and materials characterisation for pharmaceutical products and devices.

In vitro reaction phenotyping, metabolite identification and pharmacokinetic support including CES phenotyping and supersome-based assays.

Rapid forensic workflows to isolate and identify visible and sub-visible contaminants using microscopy, spectroscopy and elemental techniques to determine source and root cause.

Expertise Areas

  • Bioanalytical method development and validation
  • Ultra-trace impurity analysis (nitrosamines, NDSRIs)
  • Drug metabolism and pharmacokinetics (DMPK)
  • Extractables & leachables profiling
  • Show More (6)

Key Technologies

  • LC-MS/MS
  • High-resolution mass spectrometry (HR-MS)
  • Hydrophilic interaction liquid chromatography (HILIC)
  • Supercritical fluid chromatography (SFC-UV)
  • Show More (10)

News & Updates

Case profile describing a bursary winner presenting LC-MS/MS stability work; highlights support for early-career development and method development experience.

Report on redeveloping LC-HRMS E&L screening methods using greener solvents and runtime optimization to reduce environmental impact without loss of sensitivity.

Method development article demonstrating HILIC-MS approach for NMBA achieving 0.8 ng/mL quantification in diverse formulations.

Reported analysis of over 5,000 particles in forensic foreign-matter investigations to inform source identification and remediation.

Stated multi-site regulatory inspection success and experience with FDA, EPA, EMA, MHRA and NATA inspections and GxP-compliant systems.


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