Areas of Expertise

At AFINHES, we bring our expertise to key sectors of the health field across Africa. Our services are tailored to meet the specific needs of both public and private stakeholders in health system management, pharmaceutical regulation, and continuing education. Discover our main areas of intervention below:

Support to Health Authorities

– Pharmaceutical Policy Development (WHO Framework)

We support health authorities in designing and implementing robust pharmaceutical policies, based on WHO guidelines, to ensure access to quality medicines.

– Health Project Development

Our experts assist in the design, funding, and management of innovative public health projects aimed at strengthening local health systems and addressing population needs.

– Development of Regulatory Tools

AFINHES designs practical, tailored tools to support health product regulation, ensuring authorities are equipped to guarantee the safety and efficacy of medicines.

– Drafting of Standard Operating Procedures

We help create standardized procedures that streamline the internal processes of health authorities, ensuring smooth and compliant management of regulatory activities.

Compliance and Regulation

– Submission and Monitoring of Marketing Authorization Dossiers

We manage the preparation, submission, and follow-up of health product registration dossiers, ensuring compliance with local and international regulatory requirements.

– Strategic Support for Regulatory Challenges

In the face of regulatory blockages or complex issues, we provide strategic solutions to resolve them and speed up approval processes.

– Regulatory Intelligence

Through continuous regulatory monitoring, we keep you informed about legal changes and new requirements in the pharmaceutical sector, helping you remain compliant at all times.

Training and Publications

– Regulatory Affairs

AFINHES offers specialized training for health professionals in regulatory affairs, enhancing their understanding of registration and compliance processes.

– Pharmacovigilance Management Tools

We train teams to use advanced tools for managing pharmacovigilance systems, ensuring proactive monitoring of adverse drug reactions.

– Regulatory Affairs Delegate Training

We provide hands-on training for regulatory affairs delegates, preparing them to effectively manage interactions with health authorities and lead registration dossiers.

– Audit Preparation and Support

Our experts provide full support in preparing for and managing regulatory audits, ensuring all requirements are met and inspections run smoothly.

With our deep expertise and knowledge of the health sector in Africa, AFINHES is committed to supporting key stakeholders in achieving their goals, ensuring strict compliance and optimized health system management.