Method Development, Validation & Regulatory Support

Reliable, phase-appropriate analytical methods and associated data are necessary to ensure the quality, safety, and efficacy of drug and medical device products. Leveraging Infinity Laboratories’ national network of GMP laboratories, our team of experts have managed analytical programs for a diverse range of drugs and medical devices. This experience allows us to tap into numerous validated internal methods, accelerating your program.

Analytical Techniques Utilized

Method Development & Optimization

Method Validation

Method Transfer

Regulatory Support

Infinity meets and exceeds the need for established and documented analytic methods to provide our partners with reliable data. This dedication to excellence supports regulatory filing efficiency and quality assurance programs throughout a product’s lifecycle.
Additionally, our in-house quality assurance department ensures compliance and will host regulators or auditors as needed.

Infinity supports compliance with laws, guidances, and standards of all leading global regulatory bodies, including:

  • Code of Federal Regulations (CFR) 311.165c – Requires that the “Accuracy, Sensitivity, Specificity, and Reproducibility of test methods employed by the firm shall be established and documented.”
  • ICH GUIDELINE Q2 (R1), ICH 2005 – Establishes parameters for the validation of analytical methods.
  • Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics, FDA 2015
  • Guidance for Industry: Bioanalytical Method Validation, FDA 2018
  • USP <1225> – Validation of Compendial Methods
  • USP <1226> – Verification of Compendial Procedures
  • USP <1058> – Analytical Instrument Qualification
  • ISO 10993-18 – Chemical Characterization Testing
  • ASTM F1635 – Polymer resins and fabricated forms for surgical implants

Get in Touch

Want to learn more about our ability to support your analytical and regulatory needs throughout your product’s lifecycle? Connect with one of our team members today.