Regulatory Services

Good Distribution Practice is embedded in our DNA

Medswana is fully registered with the Botswana Medicines
Regulatory Authority (BoMRA). Through our dedicated Regulatory
Affairs department, we assist companies with their local
Botswana regulatory needs. This department exists to bridge the
gap between our global partners and the local regulations body.

Our pharmaceutical and regulatory experts work to provide consistently high quality and flexible services that enable
pharmaceutical suppliers to achieve a marketplace advantage.
Our in-house regulatory pharmacist handles product registration processes with BoMRA, getting medicines, medical devices and cosmetics regulated and to ensure right channels to market on behalf of our global pharmaceutical partners.

GDP

Good Distribution Practice (GDP) is embedded within our operations, allowing us to comply with our regulatory and legal obligations.

GDP

SOP

Our business is operated with the use of internal Standard Operating Procedures (SOP’s) to ensure all necessary steps are followed in every process.

SOP

QMS

In addition to our own internal Quality Management Systems (QMS) we also use external auditors to help stress test our business operations and to ensure regulatory compliance is maintained in accordance with ISO13485:2016 licensed in 2016.

QMS

If you have any specific inquiries or wish to engage with our regulatory department, please feel free to contact our Regulatory Manager Monique Strydom at monique@medswana.co.bw or +267 3985208. We value your partnership and look forward to providing the regulatory support necessary for your continued success in the pharmaceutical industry.