Regulatory Affairs
From registration until retention
Taking care of regulatory procedures
It can be a real challenge to stay informed about all the different local regulatory requirements, especially in Sub- Saharan Africa. As the local authorities are issuing more stringent procedures, it is important to have proper guidance. With the knowledge and expertise of our Regulatory affairs team in Belgium and our local offices in the territory, we will support you in this process. We offer a wide range in regulatory services and together we can decide whether you would like us to organise the final screening of your dossiers, or you require a more comprehensive approach by supporting you through full coordination of the regulatory work load.
In-house knowledge and expertise
We can support you at every stage of the regulatory process
With our in-house knowledge and expertise of the African markets, we assist you in the country specific regulatory requirements:
- marketing authorization application
- dossiers submission
- customs clearance of samples
- advance payment to the authorities
- transmission of queries and response submission
- registrations, renewals and variations
- annual registration retention
- etc.
Based on your preferences, we can advise you, help you prepare the country specific dossiers for submission, perform the full coordination of the regulatory workload or submit and follow-up the dossiers locally. In short, we can support you at every stage, with our personal and tailor-made approach.
Contact us now for our expertise
and support in regulatory affairs
Energia Pharma Services
Other services
Distribution
We have our bonded warehouse and logistics platform near the port of Antwerp, so it is not only close to us, but also close to our partners in Belgium, France and Portugal. To enable efficient distribution into East Africa, we have a logistical platform in Nairobi, for further distribution to our partners in Kenya, Uganda and Tanzania.
Promotion
To help you promote your products in Africa, you can count on our extensive commercial network and our own local offices in Sub-Saharan Africa. You can opt for exclusive or shared representatives; we will manage the sales force for you and we make sure we absorb all the HR, legal, logistical and financial headaches for you.
