Client
Pharmaceutical Formulation Manufacturer
Scale
35,000 sq. ft.
Delivery
14 Months
Compliance
14 Months
Challenge
The client planned to establish a new WHO-GMP-compliant manufacturing…
Client
Biotechnology Startup
Challenge
The company required a modern research facility with controlled environments, process gas systems, and regulatory-compliant laboratory infrastructure.
Scope of Work Execution
…
Client
Existing Pharmaceutical Manufacturing Facility
Challenge
The client needed comprehensive qualification and validation support to prepare for regulatory inspections.
Scope of Work Execution
Validation Master…
Client
API and Fine Chemicals Manufacturer
Challenge
The client intended to establish a sterile injectable manufacturing facility meeting WHO-GMP and international regulatory expectations.
Scope of Work Execution…
Client
API and Fine Chemicals Manufacturer
Challenge
Expansion of API production capacity while maintaining GMP compliance and process containment.
Scope of Work Execution
Process block layout
Utility system design
Equipment qualification
Environmental and containment planning
GMP documentation
Solutions
ISHA'S GMP Consultancy developed engineering designs, process flow optimization, and validation strategies for API production operations.
Impact & Outcomes
Increased manufacturing capacity
Improved regulatory compliance
Reduced cross-contamination risk
Enhanced operational productivity
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