Regulatory Affairs Consultants
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.
SPEED TO MARKET ACCESS
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.
NEW SUBMISSIONS AND FOLLOW-UPS
- Complementary medicines
- Medical devices
PRODUCT LIFE CYCLE MAINTENANCE
- Promotion and Advertising
- Variations and Line Extensions
- Registration Renewals
- Pharmacovigilance Activities
ONGOING REGULATORY INTELLIGENCE
- 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:
- For the people of Botswana to have increased access to quality medications.
- To provide top-notch service to pharmaceutical companies who need local intelligence and representation.
- To maintain a collaborative relationship with BoMRA.
The Latest From BoMRA
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.