Regulatory Compliance, Doing It Right
↓LTR/LAR Kenya
- Local Technical Representation for Pharmaceutical products
- Local Authorised Agent for Medical devices
↓Regulatory Affairs Services
- Registration of pharmaceutical products, medical devices, food supplements and all pharmaceutical related products within East Africa
- Maintenance of compliance of the above products with Health Authorities within East Africa through retentions, renewals, Good Manufacturing Practices, variations etc.
↓Pharmacovigilance Services
- Qualified Person for Pharmacovigilance (QPPV) services in Kenya
↓Distribution Compliance
- Support in implementation and ensuring of compliance with WHO GDP guidelines
↓Clinical Trials Applications
- Support in preparation and submission of clinical trial applications to the relevant Health Authorities in East Africa.
↓WHO Coordinated Scientific Advice Procedure Applications
- Assistance in navigating and submitting to the WHO Coordinated Scientific Advice platform for pharmaceutical product development guidance.
↓Other Pharmaceutical Consultancy Services
- Customised support in areas such as strategy, regulatory gap analysis, product launch planning, and market access in East Africa.
Corporate Social Responsibility
↓Public Health Education
- Chronic Disease Management
- Communicable Disease Management
- Pharmaceutical Products Usage and Management
↓Regulatory Affairs Training and Mentorship
- Offered to young pharmacists who have just completed internship
Get in Touch
Dr Alice Ngotho – BPharm, MBA, MPSK, MRAPSK, MTOPRA
Lead Regulatory Affairs Consultant / Executive Director
Email: alice.ngotho@sunesiskenya.com
Sunesis Consulting Limited: Victoria Plaza, 3rd Floor,
Parklands Road, Westlands,
P. O. Box 51269 – 00100, Nairobi