Regulatory Service
Excellence in Regulatory Compliance
At MedixCare, adherence to Good Distribution Practices is at the core of our operations.
Fully registered with the Botswana Medicines Regulatory Authority (BoMRA), we are dedicated to maintaining the highest regulatory standards.
Our specialized Regulatory Affairs department seamlessly connects global partners with local regulatory bodies, ensuring smooth compliance with Botswana’s requirements.
Our team of pharmaceutical and regulatory experts consistently delivers high-quality, adaptable services that provide pharmaceutical suppliers with a competitive marketplace advantage.
Our in-house regulatory pharmacist expertly manages product registration with BoMRA, ensuring that medicines and medical devices are properly regulated and effectively introduced to the market for our global partners.
Our Regulatory Services
01
Market Authorisation Holder
Eligible and available to act as a Marketing Authorisation Holder for products
from foreign manufacturers
02
Dossier Submissions
Facilitate dossier submissions for screening and registration with BOMRA
03
Efficient Dossier Registration
Internal reviews of dossiers and responses to queries before submission. This
ensures full compliance with BOMRA’s registration guidelines with the benefits of
minimising queries and reducing the timeline to registration.
04
Post-Approval
Activities
Post-approval activities such as Retentions, Renewals and Variations
05
Local
Representation
Local representation for pharmacovigilance (Qualified Person for Pharmacovigilance) for foreign manufacturers in line with BOMRA guidelines
SOP
Our business operates using meticulously crafted internal Standard Operating Procedures (SOPs). These procedures ensure that every process follows all necessary steps, maintaining consistent quality, efficiency, and compliance in our operations.
GDP
Good Distribution Practice (GDP) is deeply integrated into our operations, ensuring we consistently meet and exceed all regulatory and legal obligations. This commitment allows us to deliver the highest standards of quality and reliability in everything we do.
QMS
Beyond our internal Quality Management Systems (QMS), we employ external auditors to evaluate our business operations rigorously. This dual approach ensures we maintain regulatory compliance in line with BOMRA guidelines.