SCL Lifesciences

Stage Gate Adopted for API Development

Feasibility
Optimization & Standardization
Process Engineering & Safety Studies
Analytical Method Development and Validation
Crystallization & Particle Engineering
Vendor Qualification & Documentation
Genotoxic impurities & Nitroso-amine impurities risk assessment & Establishment
Kilo Lab & Scale up Studies
Exhibit Campaign as per the ICH
Regulatory stability studies for all zones
DMF filling & Packing configuration
Backward integration of KSMs to meet the regulatory requirements & cost
Development & Validation Report

Our clients say

SCL Lifesciences' has strong reputation across multiple countries establishes its CDMO services as trusted and widely approved by regulatory authorities. This global acknowledgment highlights SCL Lifesciences as a dependable partner, adept at meeting diverse compliance standards and delivering exceptional service in international markets, making it a top choice in the industry.

Diwanshu Goyal

Marketing Manager

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum.

Shyrose Erendil

Digital Marketing Manager

SCL Lifesciences' proven track record across numerous countries reinforces the credibility of its CDMO services, earning widespread trust and approval from regulatory bodies. This international recognition underscores SCL Lifesciences’ reliability in adhering to varied compliance requirements and consistently delivering outstanding solutions, partner in the global market.

John Erendil

Digital Executive

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Stage Gates for API Development Process