Regulatory Affairs
Ensuring Drug Safety, Efficacy, and Quality​
At Medilux, we provide integrated CMC services that align drug development with the latest regulatory standards, ensuring an effortless path to regulatory approval.
Our CMC Expertise
We provide end-to-end CMC services, including:
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Route of Synthesis Evaluation: Addressing potential deficiencies before submission to prevent delays or rejections.
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Key Starting Material Selection: Choosing materials based on the latest regulatory standards to ensure compliance.
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CMC Sections for Regulatory Filings for APIs: Preparation of CMC sections for IND, NDA, and ANDA registrations.
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Review & Response: Reviewing CMC sections prepared by customers and responding to deficiencies raised by regulatory bodies.
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Risk Assessments: Assessing elemental impurities (ICH Q3D), genotoxic risks (ICH M7), and nitrosamine risks as per the latest guidelines.
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Compliance & Gap Analysis: Ensuring compliance with regulatory standards and identifying gaps in existing processes.
Ongoing Compliance
CMC compliance extends beyond initial approval. We manage post-approval changes, product updates, and life cycle management, with a robust change management system to handle variations in manufacturing processes.
OUR OTHER CAPABILITIES
From molecule to market, our Centre of Excellence links discovery with scalable production.
​Research & Development
Quality by Design guides everything we do, ensuring consistency and compliance.
Quality Assurance & Control
​A robust, integrated approach keeps your supply secure and efficient.
​Supply Chain Management
Structured planning, smart resourcing, and precise oversight keep projects on track.
​Project Management
Protecting innovation while navigating complex pharmaceutical regulations.
