Our Projects
Facility Design & Qualification
- Design Conceptualization – Basis of Design
- Process and Product based design
- Qualification and Validation Support
- Renovation of Aged Facilities
- Retrofit of and Equipment to meet current standards
R&D Regulatory Submissions
RESEARCH & DEVELOPEMNT
QbD based Product Development (API and Finished Dosages)Complex and Sensitive product development servicesAnalytical Method Validation Support Product Robustness EvaluationPhase appropriate Quality Management System Design and Implementation
REGULATORY SUBMISSIONS
Preparation of Regulatory Applications (DMFs and ANDAs etc.)Review of regulatory submissions for adequacy and completeness – Question based review of applicationsCraft a strategy and justification documents for regulatory queries