Analytical Method Development & Validation
Custom method development and ICH Q2(R1) validation for novel ingredients and regulatory submissions.
Analytical method development creates custom test procedures for novel ingredients or formulations that lack existing pharmacopeial monographs, followed by ICH Q2(R1) validation covering specificity, linearity, accuracy, precision, and robustness to produce methods suitable for regulatory submission.
Not every ingredient has a pharmacopeial monograph. When existing methods don't fit your product matrix, Qalitex Laboratories develops and validates custom analytical methods tailored to your specific formulation and regulatory requirements.
Method Development Process
Our scientists start with a review of your product, target analyte, and regulatory requirements, then select the appropriate analytical platform (HPLC, GC, ICP-MS, etc.), optimize chromatographic conditions, and establish system suitability criteria. Development is typically completed in 2–4 weeks.
Method Validation (ICH Q2(R1))
Validation per ICH Q2(R1) includes: specificity/selectivity, linearity and range, accuracy (recovery studies), precision (repeatability, intermediate precision), limits of detection (LOD) and quantitation (LOQ), and robustness studies. A full Validation Report is provided for regulatory submission.
Method Transfer
If you are bringing an existing validated method from another laboratory, we perform method transfer studies to confirm the method performs equivalently in our laboratory under ISO 17025 conditions.
Ensaios e Métodos Incluídos
- ✓ Specificity & selectivity
- ✓ Linearity & range
- ✓ Accuracy (recovery)
- ✓ Precision (repeatability & intermediate)
- ✓ LOD & LOQ determination
- ✓ Robustness & system suitability
Normas Regulatórias e Conformidade
- ICH Q2(R1) method validation
- USP <1225> Validation
- FDA Guidance for Industry (analytical)
- ISO 17025 accreditation
Setores que Atendemos
- Novel ingredient suppliers
- Brands launching first-to-market formulations
- Regulatory submission support
- Contract manufacturers
- Ingredient standardization
Solicitar Orçamento
O preço depende do seu produto. Diga-nos o que precisa e enviaremos um orçamento detalhado em 24 horas.
Solicitar orçamento →Perguntas Frequentes
When do I need custom method development?
Custom method development is needed when your ingredient or formulation does not have an existing pharmacopeial monograph (USP, AOAC), or when existing methods do not adequately separate or detect your target analyte in your specific product matrix.
What does ICH Q2(R1) method validation include?
ICH Q2(R1) validation includes specificity/selectivity, linearity and range, accuracy through recovery studies, precision (repeatability and intermediate), limits of detection and quantitation (LOD/LOQ), and robustness studies. Qalitex provides a full Validation Report suitable for FDA submission.
How long does method development take at Qalitex?
Method development at Qalitex is typically completed in 2–4 weeks, including analytical platform selection, chromatographic optimization, and system suitability criteria establishment. Full ICH Q2(R1) validation follows development and adds an additional 2–4 weeks.
Páginas de Ensaios Especializados
Method Development for FDA compliance
analytical method development validation for FDA compliance
Method Development for Amazon listing approval
analytical method development validation for Amazon listing approval
Por que as marcas escolhem a Qalitex para analytical method development & validation
Entrega em 48 h
CoA assinado em 48–72 horas
Acesso direto ao cientista
Fale com o químico que realiza seus ensaios
Sem mínimos
1 SKU ou 100 — mesma qualidade
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Quality & AccreditationISO 17025 Lab: How Accreditation Elevates Testing Accuracy and Reliability
Understand how ISO 17025 accreditation transforms laboratory operations, from method validation and equipment calibration to continuous improvement — and why it matters for the brands that depend on lab results.
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Solicitar orçamento →Aviso legal: Os resultados de ensaios fornecidos pela Qalitex Laboratories são dados analíticos destinados a fins de controlo de qualidade. Não constituem aconselhamento jurídico, regulatório ou de conformidade. Os clientes são os únicos responsáveis por garantir que os seus produtos cumprem todas as regulamentações aplicáveis.