Lck Pharmaceutical Consulting

LCK Pharmaceutical Consulting is a regulatory affairs, pharmaceutical consulting and quality systems firm supporting pharmaceutical manufacturers, regulatory authorities, and development partners across Africa and other low- and middle-income countries (LMICs). We provide strategic, technical and operational support across the full spectrum of regulatory and quality systems functions, including: Regulatory Strategy & Dossier Development CTD/eCTD preparation, variation management, lifecycle maintenance, and submission readiness across Africa, the Middle East, and Asia. Clinical & Bioequivalence Evaluation Expert assessment of clinical trial data, pharmacokinetic studies, and bioequivalence reports in alignment with WHO, EMA, and US FDA standards. GxP Compliance & Quality Systems Strengthening GMP, GCP, GLP, GSDP, data integrity, internal audits, mock inspections, SOP development, gap assessments, and laboratory quality management. Regulatory Systems Strengthening Support to Ministries of Health and NRAs on regulatory capacity building, WHO GBT alignment, harmonization (EAC, SADC, ECOWAS), reliance mechanisms, and quality management systems. Training & Capacity Building Practical, case-based programmes for regulators, manufacturers, and QC/QA teams, including GRP, GMP, Clinical Evaluation, Data Integrity, BE Level 1–3, CTD/eCTD, GLP/GCP, and Quality Systems. Our mission is to strengthen regulatory systems, improve the quality and safety of medical products, and advance local manufacturing capability across Africa. Our clients include: Pharmaceutical companies • BE Centres • Ministries of Health • National Regulatory Authorities • Global health organizations • Development partners • Innovators & start-ups. Let’s partner to advance regulatory excellence and promote access to safe, effective, quality medical products.