Φ Product Analysis
Φ Analytical method validation, dissolution and stability studies (as per ICH)
Φ Complete database for analytical data
Φ Drafting active - specification, certificate of analysis and method of analysis
Φ Drafting non-active - specification, certificate of analysis and method of analysis
Φ Drafting packing material - specification, certificate of analysis and method of analysis
Φ Drafting pre-formulation, BMR, MFR, process validation, method validation, dissolution and stability studies documents
Φ Product registration assistance
Φ Product development assistance
Format: As per country specific regulatory guideline / ICH / Asean CTD / EuCTD
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