Isha’s GMP services delivers high-quality services within timelines reliably and economically. Isha’s GMP services is focused on delivering value, growth with continuous learning. We are here to meet your highest expectations.
Product Development Services
Literature Search
I P Review
Pre-Formulation Development
Compatibility Studies
Formulation Development and Optimization
Packaging Development
Process Development and Optimization
Scale-Up and Technology Transfer
Process Validation Studies
Analytical Development Services
Analytical methods development and validation
Cleaning methods development and validation
Stability studies as per ICH Guidelines
Method Transfer
Intellectual Property Right
Landscape Preparation
Support for formulation development IP related activities
Infringement and Non-infringement Analysis
ANDA Certifications
Pharmacokinetic Department
Bio-Study protocols preparation and planning of Bio studies
Bio equivalence study monitoring.
Review of Bio study report and supporting for Regulatory submission
Isha’s GMP services provides excellence in quality and compliance. We support the services throughout the entire process of planning, selecting, designing and developing to meet the growing demands of the global market standards.