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:
-
Route of Synthesis Evaluation: Addressing potential deficiencies before submission to prevent delays or rejections.
-
Key Starting Material Selection: Choosing materials based on the latest regulatory standards to ensure compliance.
-
CMC Sections for Regulatory Filings for APIs: Preparation of CMC sections for IND, NDA, and ANDA registrations.
-
Review & Response: Reviewing CMC sections prepared by customers and responding to deficiencies raised by regulatory bodies.
-
Risk Assessments: Assessing elemental impurities (ICH Q3D), genotoxic risks (ICH M7), and nitrosamine risks as per the latest guidelines.
-
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.
