Regulatory Affairs Consultants
of Botswana

Regulatory strategy that works and collaborative ongoing interactions with the Botswana Medicines
Regulatory Authority (BoMRA) through a local expert.

high quality applications

Build a winning reputation with BoMRA.


Eliminate unnecessary delays.


Market your products with confidence.

Managing interactions with BoMRA internationally can be frustrating.


Do you have a local technical representative in Botswana?

Is your regulatory knowledge insufficient to make regulatory decisions for the Botswana market?

Are you worried about the quality of your regulatory submissions?

Is there a gap in your interactions with BoMRA?

Are your products carrying unnecessary regulatory risk?

Do you know if there are concerns about your products in the market?

Unknown factors can jeopardize your company’s reputation.
You deserve a local partner you can trust so you can market your products with confidence.

Develop a regulatory strategy that works.



  • Pharmaceuticals
  • Complementary medicines
  • Medical devices
  • Cosmetics


  • Promotion and Advertising
  • Variations and Line Extensions
  • Registration Renewals
  • Pharmacovigilance Activities


  • Contact continuity with BoMRA
  • Efficient and collaborative relationship with BoMRA
  • Regulatory strategy

Your Botswana Team

Maintaining good regulatory practice internationally is challenging. We understand the complexity of working with BoMRA, especially without quality local representation. Botswana’s new legislation has resulted in a rapidly changing regulatory environment towards greater stringency. You need local experts.

We are a team of regulatory experts with years of experience working with the Botswana Medicines Regulatory Authority (BoMRA) and the Drugs Regulatory Unit (DRU) which preceded it. We diligently maintain our excellent reputation with the health authority as well as local medical, veterinary, and distribution stakeholders.

Stonebridge represents pharmaceutical companies from global giants to boutique firms. We simplify end-to-end regulatory activities. This includes developing, submitting, acquiring and maintaining licenses. We support their importation, distribution, sales & marketing efforts by ensuring good regulatory practice.

Working With Us is Simple

1: Let's Talk

We’ll schedule a call to get to know you and make a custom plan.


2: Register Your Products

We’ll help you through the process, step by step.


3: Thrive in the Market

Keep your product registered with BoMRA throughout its lifecycle.

We Bridge the Gap Between Our Clients and BoMRA.

Our team provides end-to-end regulatory support to our clients. We clear the regulatory fog many companies experience and simplify their regulatory strategies. Our goal is to improve the success rate of our clients’ regulatory activities in Botswana, and bridge the gap between them and BoMRA. 

Led by a patient-centered pharmacist with a team of locally based regulatory consultants, Stonebridge Regulatory Consulting exists for three reasons:

  1. For the people of Botswana to have increased access to quality medications.
  2. To provide top-notch service to pharmaceutical companies who need local intelligence and representation.
  3. To maintain a collaborative relationship with BoMRA.

The Latest From BoMRA

Important Stakeholder Meeting for the Registration of Medicines

On the 19th of October 2020, BoMRA hosted a human medicine stakeholder meeting. This meeting was critical and was aimed at clearing the regulatory fog of human medicine in Botswana. The meeting brought light into both logistical and technical expectations of BoMRA...

Botswana’s economy reopened

After 49 days of extreme social distancing and the close of all non-essential services across the country, the government of Botswana authorized all services to reopen on May 21st, 2020. To date, Botswana has only registered 35 confirmed cases of Covid-19 and 1 death....

Is BoMRA Accepting Human Medicines Registration Applications During the COVID-19 Lockdown?

Yes, BoMRA has indicated that they will continue accepting, evaluating and registering human medicinal products during the COVID-19 lockdown. Submissions and all correspondence may only be sent electronically. Applicants may not submit samples until further notice....

President Masisi Declares a State of Emergency in Response to COVID-19

In response to three confirmed cases and one death due to COVID-19, and returning citizens and residents to Botswana from highly effected countries, President Masisi declared the State of Emergency. In his speech, he outlined the following: From April 2nd midnight,...

Three Covid-19 Cases Confirmed in Botswana

On March 30, Botswana confirmed the first 3 cases of Covid-19 cases after testing 191 people - two men and one woman. The government reported that two of the three patients recently been in Thailand and one in the UK. The three patients are isolated in a hospital and...

Mandatory 14 Day Quarantine for Travelers from South-Africa.

To date, Botswana has not recorded any Coronavirus cases. The country is determined to keep this record for as long as possible. The Botswana Ministry of Health has decided that only citizens and residents will be allowed to enter the country following a mandatory 14...

BoMRA Response to COVID-19

This is an outline of BoMRA's plan for the ongoing management of the medical supply chain and interactions with stakeholders during the COVID-19 pandemic. We recommend reading the entire publication. Please take special note of the following: All meetings scheduled...

BoMRA Introduces Paid Regulatory Services

Since the introduction of the regulation of medicines in Botswana in 1993, almost all regulatory services have been free. The only paid service was the evaluation of dossiers which costed P500 per application. On the 06 of January 2020, BoMRA made an announcement of...

BoMRA Intensifies their Vigilance on the Market

For many years, counterfeit, unregistered and falsely labeled products have been populating the Botswana market. The market for authentic products was taken and replaced by adulterated products. This has been a concern to many prescribers, pharmacists, distributors...

The Transfer of Regulatory Services from DRU to BoMRA.

On November 14th, 2018, The Ministry of Health (MOH) informed all stakeholders that all regulatory functions will be transferred from the Drugs Regulatory Unit (a MOH Unit) to the newly formed Botswana Medicines Regulatory Authority (BoMRA). This will effect on...

Request a Product Registration

We understand that there are products needed in Botswana that have not been registered yet. This page is dedicated to healthcare professionals and other stakeholders who need support to access a product. This form is for basic information about what is needed, and we will follow up through email for more information.

Stonebridge Regulatory Consulting does not provide marketing, sales, or distribution services for our clients. We may act as Local Technical Representatives, oversee pharmacovigilance activity, hold power of attorney, and support regulatory compliance as it relates to sales, marketing, and supply chain (importation and distribution).