Regulatory Compliance & Quality Assurance
Uncompromised Regulatory Excellence
Navigating the complex landscape of global pharmaceutical regulations requires expertise and diligence. L&M provides end-to-end regulatory support, ensuring your products meet the rigorous standards of international health authorities (FDA, EMA, PMDA).
Global Regulatory Affairs
We maintain strict adherence to all relevant pharmaceutical regulations. Our expert team facilitates the preparation and submission of DMFs (Drug Master Files), CEPs, and other regulatory dossiers, ensuring smooth approvals and market entry across varied jurisdictions.
Quality Assurance Systems
Our comprehensive quality management includes rigorous audits, batch record reviews, and stability data evaluation. We ensure total traceability and accountability, safeguarding patient safety and your brand reputation at every step.
Our Standards of Quality
Rigorous adherence to international benchmarks.
GMP Certified
Full compliance with Good Manufacturing Practices.
ISO Standards
Adherence to ISO 9001 and ISO 14001 quality systems.
FDA Compliant
Meeting the stringent requirements of the US FDA.