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Analytical Method Development and Validation

MYdossier offers complete analytical method development, method validation and transfer services through a dedicated staff of knowledgeable and experienced pharmaceutical scientists. MYdossier has experience in support of various dosage forms within the generic and branded pharmaceutical industries. We perform validation as per ICH guideline, which is acceptable to MOH/FDA of Asian, African, CIS, Latin American and rest of world. We also handle all queries related to validation which is raised by MOH/FDA.

As your research partner, we provide detailed protocol, report and chromatograms for method development and validation. We provide a report at the conclusion of each Validation project. Included within this report is the analytical method itself which is written in a step-by-step format (which is acceptable at MOH/FDA during product registration).

Validation Services for:-
- Assay - Method validation
- Dissolution - Method Validation
- Related Substance (impurities) - Method Validation
- Identification - Method Validation

Products:- Pharma Formulation, Bulk (API), Food & Veterinary

Analytical validation: - As per ICH / ASEAN / WHO / other country specific guideline

HPLC used for Validation:- Shimadzu LC-2010 (Fully automated with most advanced technologies)