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Services offered
- Method development and validation
Our protocols comply with the requirements of regulatory authorities in the USA and Europe.
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- We offer method development, validation and routine analysis for:
- Assay in bulk and formulated materials
- Drug levels in serum, plasma, urine and tissues
- Impurities, degradation products and TRS
- Cleaning validation for facilities
- Dissolution: Routine tests and method development
- Stability trials for bulk material and formulated products
- Residual solvents and OVI by headspace gas chromatography
- Five batch analysis for technical and formulated pesticides
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Special R&D services
- Separation and identification of active compounds from biological (plant and animal) matrix
- LC-MSn
Separation and identification up to molecular structure of impurities and degradation products in bulk and formulated pharmaceutical products.
Consultation Analyst
Offers comprehensive consultation services covering all analytical and regulatory (analytical aspects only) issues.
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