RA – HEMEX

Committed to Regulatory Compliance

HEMEX Regulatory Affairs provides advice for pharma and med-tech products through all life cycle stages of the regulatory journey, from development, and registration to post-market activities.

We support startups with EU, FDA, and Swissmedics submissions. Moreover, using our SME status at EMA, HEMEX can act as a Marketing authorization applicant in the EU for Swiss startups.

Let's talk

Experience in Pharma & Biotech, and MedTech & IVD

Fast and effective advice

Benefit from a streamlined organization

Concrete and pragmatic solutions

Committed to Regulatory Compliance

HEMEX Regulatory Affairs provides advice for pharma and med-tech products through all life cycle stages of the regulatory journey, from development, and registration to post-market activities.

We support startups with EU, FDA, and Swissmedics submissions. Moreover, using our SME status at EMA, HEMEX can act as a Marketing authorization applicant in the EU for Swiss startups.

Let's talk

Experience in
Pharma & Biotech, and MedTech & IVD

Fast and effective
advice

Benefit from a
streamlined
organization

Concrete and
pragmatic solutions

Our Solutions

We provide full-service regulatory support & assistance.

Regulatory Strategy
Regulatory Strategy Implementation
Gap Analysis for MDR/IVDR Transition
Clinical Evaluation Report (CER)
510(k) Preparation & Submission

Contact us for more

“To ensure market access, our regulatory affairs team brings years of experience and insights gained from working on several projects to help you adapt to the constantly changing regulatory environment.”

Our Solutions

We provide full-service regulatory support and assistance.

Regulatory Strategy
Regulatory Strategy Implementation
Gap Analysis for MDR/IVDR Transition
Clinical Evaluation Report (CER)
510(k) Preparation & Submission

Contact us for more

SME Status Application

Are you qualified as SME?

In this case, you are entitled to a consultation fee reduction from regulatory bodies.

Our team can assist you throughout the application process.
Or you can utilize HEMEX’s SME status within the EU.

What customers say about us

HEMEX provides Scailyte a range of services, from administrative to highly specialized regulatory and clinical development support. Working at HEMEX incubator, whenever we have a question, we can immediately address it. We’re happy to continue our journey with such a trusted partner.

Dr. Peter Nestorov

CEO, Scailyte

With its impressive commitment to advance and fund healthcare innovations, its deep understanding of startup needs and its solid expertise in supporting regulatory and clinical operations, HEMEX is an exceptional partner that has been and continues to be instrumental in our journey.

Mathieu Horras

CEO, ASPIVIX

“At HEMEX, we have changed the game. We devote our minds and hearts to the startups we work with. Our mission is to truly move your business forward by powering your clinical research development, quality management, and regulatory affairs.”