Pharmaceutical & Biopharmaceutical

Inspired Pharmaceuticals

Your drug formulations, finished products, drug substances, and raw materials are tested to ensure compliance to FDA cGMP, ICH, and applicable regulations. Based on our understanding of the product development life cycle, quality processes are applied to specified product development phases.  We work closely with our clients to meet their testing needs from the request submission to the final report. Some of these services include:

  • Method Development and Validation
  • Method Transfer and Qualification
  • Early Screening and Pre-formulation Studies
  • Cleaning Protocol Validation
  • Method Comparability Studies
  • Compendia Method Verification Studies
  • ICH Stability Studies
  • Stress Stability/Accelerated Aging Studies
  • Container Closure Compatibility Testing
  • Extractables and Leachables Testing
  • Process Optimization & Qualification Support
  • Drug Substance and Drug Product Characterization
  • Clinical Supplies & Product Release Testing
  • Drug Dissolution and Elution Studies
  • Second Source Qualifications

Biopharmaceutical Analytical Services

At ChRi Labs, we understand that each biologic, whether small or large molecule is unique. We provide analytical services for formulation research and development of biopharmaceutical drugs such as proteins, peptides, monoclonal antibodies, nucleic acids, etc. We use various extraction and detection techniques to assess unique biologics from complex matrices. Our goal is to select the best scientific technique to isolate and accurately separate the key analyte(s) of interest, no matter the sample size. Our bioanalytical services include: 

  • Method Development and Validation
  • Macromolecule Separations
  • ELISA Development and Validation
  • Nanocapsules and Microspheres Analytical Development
  • Peptide Mapping
  • SDS PAGE Gel Electrophoresis
  • Bioequivalence Studies
  • Sample Extraction Techniques
  • Analyte(s) Stability Studies
  • Sample Analysis, Sample Management, and Storage