IGRS provides services in the following:
Analytical Method Development Analytical Method Validation
Routine analyses of products - HPLC/GC/MS/ etc.
Total Product Characterization
Impurity profiling
Stability studies
Total development of product from lab scale to pilot plant scale to actual production scale. This services includes both for Medicinal Drug Product Formulation and Medicinal Drug Substances API.
IGRS has the necessary staff who have excellent exposure to software, automation, pharmaceutical R&D, production, regulatory practices and audits, etc., who can perform independent validations of your automation and software and provide a detailed report, acceptable to the FDA.
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