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Method Development & Validation

Nimble Approach to Complex Methods

Our analytical method development team produces accurate and reliable methods that deliver consistent results.  If you need experienced method development chemists to measure the concentration of an active pharmaceutical ingredient (API) in a specific compounded dosage form, Avomeen can help. If you need to identify and quantify 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.

Whatever your scientific business challenges, Avomeen can resolve them. Our multi-disciplinary chemists specialize in non-routine testing and have successfully completed thousands of projects, on time and on budget. We regularly provide pharmaceutical method development services, and our laboratory is FDA-registered, DEA-licensed, and GMP-compliant.

 

Method Validation in Pharmaceutical Analysis

Beyond 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 time and cost 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 need to transfer a validated analytical method to a new site, Avomeen can document and perform the method transfer. Our chemists can even provide training to the team at the receiving laboratory to make sure the method transfer meets regulatory requirements. Whether your product requires comparative testing or inter-laboratory method validation, we have the resources to ensure your method transfer goes smoothly.

If you have a method development or validation project that cannot be done in-house due to its complexity, or you need the work completed on a tighter schedule 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

 

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 and 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 • Particulate Identification
• 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 • Low-level Genotoxic Impurities
• 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)

Analytical Techniques Utilized

Techniques commonly utilized include GC/MS, GC, 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 our instruments’ raw data.

 

Why Partner with Avomeen?

Decades of experience, the capability to tailor protocols and study designs, and a readiness to take on complex and non-routine analyses results in our ability to offer a comprehensive, all inclusive-solution to our clients.

 

Industry Leadership

Our wide-reaching capabilities incorporate industry-leading knowledge and expertise in the biopharma research, formulation, and regulatory processes. We’ve been helping to improve healthcare and speed time-to-market working with leading therapeutics and medical devices.

 

Technical Tenacity

When routine testing laboratories don’t have the experience or qualified experts to take on a project, they pass it on to the next laboratory. When those projects come to Avomeen, they get done. Our unique blend of scientific, regulatory, and legal knowledge allows us to problem-solve from unusual angles. If it’s the right scope, we say yes when others say no.

 

Ph.D.-Backed Projects

Every Avomeen project is backed by Ph.D. scientists who specialize in the regulatory knowledge and scientific applications specific to life sciences. When you put your project in the hands of our specialists, you can trust your results reflect the unparalleled knowledge of our industry-leading scientific minds.

 

The Avomeen Experience

We excel in building partnerships with our clients to ensure success in every stage of the development process from discovery to post-market, including life cycle management. Our dedication to our clients is apparent in everything we do. We work with you to tailor our processes to your program while maintaining scientific integrity and ensuring compliance to regulatory requirements.

 

We’re Not Just Any Lab. We’re Your Lab.

We provide unmatched, complete solutions by working hands-on with you to tailor every test and consultation to your ever-changing needs.

 

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Ready to Partner? So are We.

Request a quote or ask an experienced scientist today.