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 particular compounded dosage form to the multitude of constituents in a formulation, we can monitor your product’s purity, composition, and potency.

Beyond method development, our skilled chemists can validate or verify existing methods to help ensure cGMP compliance of regulatory submissions.  Our team also can improve upon existing methods by identifying gaps and proposing a detailed remediation plan.  This can even include tailoring existing test procedures to your drug substance or drug product, which can save on both time and costs in developing an analytical method.  Our laboratory can work with not only standard chromatographic methodology but also complicated LC-MS method validations, protein analysis, and other complex assays.  Our experienced staff can develop methods for the most complex formulations within your time frame.  We can 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 timeframe 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 pharmacopeias for a particular 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

Support of Multiple Dosage Forms:

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

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

  • Potency & Purity Methods
  • 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
  • Other custom Assay Development

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

Analytical Techniques Utilized

Techniques commonly utilized include HPLC, GC, LC and GC/MS, UV/Visible spectroscopy, ICP-MS, and NMR.   Our analytical method development, validation, or transfer services reports include protocols, methods, and other pertinent data.

Contact Avomeen to request a quote: