Amerise Pharmaceutical is highly specialized in the development of complex formulations. Amerise Pharma adopts a Quality by Design (QbD) approach, applying and challenging possible technologies in order to deliver the optimal product profile and performance in a timely and efficient manner.
Amerise Pharma supports 505(b)(2) regulatory pathways. Our facilities and teams are designed/equipped to provide flexibility while maintaining quality services. We provide end to end regulatory filing support through CMO partners.
Amerise Pharma offers proven expertise in providing regulatory-compliant & cost-effective Pharmaceutical product development for regulated markets.
Amerise EXPERTISE + DEDICATION + RESOURCES = YOUR SUCCESS
Formulation Capabilities
Parenteral Products: Complex injectables (including Protein & Peptide molecules), Bio-Similar Injectable, Liquid injections (TS & Aseptic), PFS, Lyo-Injectable, Injectable Suspension and Lipid Based Injectable products.
Liquid Orals: Suspension, Powder for Suspension, Dry Syrup and Syrups.
Complex Oral Dosage Forms: Tablets, Capsules and Modified Release Dosage Forms
Analytical Capabilities
Method Development and Validation as per ICH Guidelines
Analytical Method Transfer
Reverse Engineering to establish Q1 (Qualitative) & Q2 (Quantitative) composition
