Question 1

What kind of regulatory support do you provide?

Accepted Answer

We provide regulatory pathway assessment and guidance, as well as support for ethics and regulatory submissions.

Question 2

Do you support clinical studies directly?

Accepted Answer

Yes. Our services include clinical study design and implementation, clinical validation and usability studies, and data collection, analysis, and reporting.

Question 3

Can you help with ethics and regulatory submissions?

Accepted Answer

Yes. Support for ethics and regulatory submissions is part of this service.

Question 4

Who is this service for?

Accepted Answer

We support MedTech innovators, healthcare organizations, and researchers.

Question 5

What regulatory bodies do you typically work with?

Accepted Answer

We help map the relevant regulatory pathway for a given device and market, working alongside the applicable national and regional regulatory bodies and ethics committees.

Question 6

How early should regulatory planning start?

Accepted Answer

As early as possible. Regulatory pathway assessment is most useful during design and development, not after a device is finished, since it can shape design and testing choices.

Question 7

Do you support clinical studies outside Kenya?

Accepted Answer

Our clinical study support is shaped around the regulatory and healthcare-facility context of wherever the study is taking place.

Regulatory Navigation and Clinical Study Support FAQs

Common Questions About Regulatory Navigation and Clinical Study Support