Whether it's reviewing existing data, performing a gap assessment, supporting an audit or CAPA, ensuring compliance to EU MDR or developing new testing strategies, we will provide the support your project needs.

Microbiology

• Bioburden Evaluation

• Endotoxin Evaluation

• Microbiological Investigations

• Cleanroom and Controlled Environments

• Lab Design

• Equipment IQ/OQ/PQ

• Test Method Validation

Sterilization

• Sterilization Validation

  • Ethylene Oxide (EO)​

  • Gamma Irradiation

  • E-Beam Irradiation

  • Steam/Autoclave

  • Vaporized Hydrogen Peroxide (VHP)

  • Vaporized Peracetic Acid (VPA) & Peracetic Acid (PPA)

  • Nitrogen Dioxide

Reprocessing

• Cleaning

• Low-Level Disinfection

• High-Level Disinfection

• Reusable Device Sterilization Validation

• Test Method Validation

• Instructions for Use (IFU)

• Performance/Functionality Evaluations

• Material Compatibility

Biocompatibility

• Biological Safety Evaluations

• Biocompatibility Risk Assessments

• Biocompatibility Plans, Protocols, Reports

• Gap Assessments

• EU MDR Remediation

• Material Biocompatibility

• Rationale/Justification

Chemistry

• Chemical Characterization

• Extractables and Leachables

• Testing Strategies

• Targeted Compound  Quantification

• Assessment of Identified/Quantified Chemical Compounds

• Drug Stability/Compatibility Assessments

Industries

Vegan Products

Microbiome Products