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 Pathway
  • Seeking Scientific Advice
  • Pre-Submission Meetings
  • Notified Body Selection
  • Liaison with Health Authorities
  • Gap Analysis
  • MDR/IVDR Transition
  • Technical Documentation
  • Technical Assessment Reports
  • EU Representative (learn more)
  • For other RA Services get in contact!

“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 Pathway
  • Seeking Scientific Advice
  • Pre-Submission Meetings
  • Notified Body Selection
  • Liaison with Health Authorities
  • Gap Analysis
  • MDR/IVDR Transition
  • Technical Documentation
  • Technical Assessment Reports
  • EU Representative (learn more)
  • For other RA Services get in contact!

SME Status Application

Are you qualified as SME or SBD (Small Business Determination in the USA)?

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.

“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.”

SME Status Application

Are you qualified as SME or SBD (Small Business Determination in the USA)?

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

Ready?

1.

Start the conversation

2.

Discuss your situation

3.

Receive a proposal

4.

 Let’s get you to the market!

Ready?

1.

Start the conversation

2.

Discuss your situation

3.

Receive a proposal

4.

Let’s get you to the market!

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QMS training/workshops

 

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