Competency

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 the greatest 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.

OUR EXPERTISE + OUR DEDICATION + OUR FACILITIES = YOUR SUCCESS

Formulation Capability

Parenteral product : Sterile liquids , Liquid injections (TS & Aseptic), PFS, Lyo-Injectable, Bio-Similar Injectable, Liquid injection
Liquid Orals : Suspension, Emulsion, Dry Syrup and Syrups
Topical product : Cream, Gel, Lotion, Ointment, Solution
Oral product : Tablets, Capsules

Analytical Capability

Q1,2,3 Method development and Validation as per ICH
Method transfer
- Characterization of brand products of bio similar products
- FDA Query Response