REGISTRATION

STRATEGY

You will receive valuable and realistic advice with support for your drug registration strategy, for both human and veterinary medicines.

Our team will anticipate any future issues or challenges and will ensure that you are prepared to overcome them on timely basis

• Advice on registration strategy: legal basis and selection of registration route

• Management of drugs registration processes in Kenya, Uganda, Tanzania, Rwanda, Malawi, Zambia, Botswana, Ethiopia and South Sudan

• Coordination and the preparation of your marketing authorization application

• Provide a project plan and timeline for the registration of the products

DRUG REGISTRATION DOCUMENTATION

• Dossier preparation and submission to National Medicines Regulatory Authority (NMRA)

• Timely compiling and submission of dossiers

• Submission of dossier to other regional agencies in African countries

• Regular follow up of submitted documents to ensure timely registration

• Timely responses to issues raised in the registration process

• Application of annual products licencing

• Preparation of technical labelling information for packaging materials, leaflets and advertising materials and brochures.

• Participate in the formulation of registration guidelines by NMRA