Qualiculture

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 services
Analytical Method Validation Support Product Robustness Evaluation
Phase 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 applications
Craft a strategy and justification documents for regulatory queries