Working Method – Genorra Lifescience
How We Develop and Deliver Products at Genorra Lifescience
At Genorra Lifescience, every product goes through a structured, compliant, and quality-driven pathway. Our process ensures that each formulation meets the regulatory, safety, and performance standards of the countries we serve.
Vendor Development & Raw Material Qualification
We begin by identifying and qualifying trusted vendors for raw materials (RM) and packaging materials (PM).
Only approved suppliers meeting global quality standards are selected.
01
Product Development as per Country Regulations
Our R&D team develops each product according to the specific regulatory requirements of the target country—ensuring accuracy, safety, and compliance from day one.
02
Method & Process Validation
Analytical methods and manufacturing processes are validated to guarantee:
⦁ Consistent product quality
⦁ Reproducibility
⦁ Regulatory acceptance
03
Stability Studies
We establish product stability as per the guidelines of the respective regulatory agencies.
This ensures the product remains safe, effective, and compliant throughout its shelf life.
04
Regulatory Submission & Approvals
Dossiers are prepared and submitted for approval to the respective country’s regulatory authority.
We manage the entire communication and review process until approval is obtained.
05
Scale-Up & Manufacturing
Commercial-scale manufacturing is carried out in facilities compliant with:
⦁ cGMP
⦁ WHO guidelines
⦁ EU and USFDA regulatory standards
All production batches undergo rigorous quality control.
06
Packaging & Labeling Compliance
Packaging and labeling are developed to meet the regulatory and artwork requirements of each destination country, ensuring clarity, accuracy, and market compliance.
07
Final Delivery
We deliver products within the committed timelines, ensuring they meet the highest standards of:
⦁ Quality
⦁ Safety
⦁ Efficacy
⦁ Regulatory compliance
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