Method Development & Validation, Method Verification, & Method Transfer

Our analytical method development team can produce accurate and reliable methods that deliver consistent results.  From measuring the concentration of an active pharmaceutical ingredient (API) in a specific compounded dosage form to identifying and quantifying the excipients, intermediates, raw materials, preservatives, antioxidants, impurities and more within a formulation, we can ensure that your product maintains the proper identity, purity, potency, and performance.

Beyond just method development our skilled method validation chemists can verify existing methods to help ensure approval of regulatory submissions.  Our team can also improve upon existing methods by identifying gaps and proposing a detailed remediation plan.  This can even include tailoring existing test methods to your drug substance or drug product, which can save on both times and costs in developing an analytical method.  Our contract research lab can even take on difficult LC-MS method validations and complex ELISA assays.  Our experienced staff can develop methods for even the most complex formulations within your timeframe.  We develop custom proposals to complete the analyses you require when certifying a new drug product or amending a current drug application.

If you have a method development or validation project that cannot be done in-house due to its complexity, or you need the work performed in a faster time period than your in-house laboratory can handle, Avomeen can help.  As development partners, we can design detailed protocols for method development, validation, and technology transfer based on the product’s phase in the drug development process.

What Necessitates the Development of Analytical Methods During Drug Development?

  • Lack of methods in any pharmacopoeias for a specific drug or drug combination
  • Existing procedures require expensive reagents or solvents, require highly complex extraction or derivatization procedures, or may not be reliable

Analytical Method Development & Validation Protocols for Raw Materials & Finished Products Including:

  • Pharmaceutical Ingredients (API’s), Drug Formulations, Nutraceuticals & Biopharmaceuticals
  • Immediate & Modified Release Formulations
  • Polymers & Coatings
  • Small & Large Molecules
  • Cosmetic & Personal Care Products
  • Raw Materials

Capable Support of Multiple Dosage Forms:

  • Injectables (Lyo & Non-Lyo)
  • Solids, Semi-Solids & Liquids
  • Inhalation/Nasal
  • Transdermal & Suppository

Our scientists develop custom CDER/ICH and FDA Method Development & Validation protocols based on established guidelines.  All methods are tested under strict internal and external requirements, we can develop methods for:

  • Custom Assay Development
  • Potency & Purity Methods
  • Complex Method Validation
    • Accuracy & Recovery
    • Precision (Test/Re-Test Reliability & Intermediate Precision)
    • Specificity & Selectivity
    • Limit of Detection (LOD)
    • Limit of Quantitation (LOQ)
    • Linearity & Range
    • Samples Stability in Matrix
    • Stock Solutions Stability
    • Specificity
    • Homogeneity
    • Ruggedness
    • Robustness

Method Development & Validation Studies For:

• Characterization of Drug Substances • Pharmacokinetic, Bioavailability & Bioequivalence • Method Transfer & Training
• Analytical Standard Characterization • Release Testing & Evaluation • Formulation Development
• Reference Standard Qualification • Drug Excipient Compatibility Studies • Product Deformulation
• Active Assay & Related Substances • IND Phase-Appropriate Method Validation • Comparative Studies
• Gap Analysis & Remedial Validation • Process Impurity • Vendor Qualification
• Extractables & Leachables • Chromatographic & Chiral Purity • USP Method Testing
• Solubility & Solution Stability Studies • Residual Solvents Analysis • ELISA Assay
• Stability Indicating Assays • Peak Identification • Column Equivalency Studies
• Prototype Evaluation – Accelerated/Stress Studies • Cleaning Procedures Validation • Technical Consulting
• Forced Degradation Studies • Cleaning Residual Assays • Counterfeit Product Evaluation
• Dissolution Testing • Process Validation & Remediation Support • Material Contact Studies
• Preservative Assays • Physical Methods • Method Life-Cycle Evaluation Studies
• Preservative & Stabilizing Excipients Assays • Nasal Spray Characterization • Lyophilization Cycle Design (DSC)
• Polymer Identification (FTIR or NMR) • Particulate Identification • Low-level Genotoxic Impurities

Techniques commonly utilized include GC/MS, GC, AA Spectrophotometry, UV/Visible spectroscopy, ICP-MS, and HPLC.   Our standard analytical method development, validation, or transfer services report includes a copy of the analytical method, copy of all test results and protocols, appropriate calculations and graphs, and out instruments raw data.

Contact Avomeen to Arrange a Free Initial Consultation With One of Our Ph.D. Chemists
Call: 800-930-5450