At Medkem, quality and regulatory compliance form the foundation of our API sourcing, formulation support, and CDMO activities. Our systems and partner facilities operate in alignment with internationally accepted regulatory standards to ensure product quality, patient safety, and data integrity.
- Quality Assurance
A comprehensive Quality Management System (QMS) governs API, formulation, and CDMO operations, covering change control, deviation and CAPA management, risk assessment, validation oversight, and continuous improvement in compliance with cGMP requirements. - Regulatory Compliance
All activities and associated manufacturing sites comply with applicable global regulatory standards, includingUSFDA, EU GMP, WHO-GMP, ICH, and other relevant guidelines, supporting development, scale-up, and commercial supply for regulated and semi-regulated markets. - Regulatory & Technical Documentation Support
End-to-end documentation support for APIs, formulations, and CDMO projects, includingDMFs (API/Formulation), Certificates of Analysis, impurity profiles, method validation reports, stability data, validation documents, and product registration dossiers, facilitating regulatory submissions, audits, and inspections. - Supplier & Manufacturing Partner Qualification
A formal qualification and ongoing monitoring process is applied to API manufacturers, formulation sites, and CDMO partners, includingquality system assessments, regulatory status verification, on-site or remote audits, data integrity review, and performance tracking to ensure compliance, traceability, and continuity of supply.
Our compliance-driven approach ensures regulatory readiness, audit confidence, and reliable product lifecycle support from development through commercialization.