Regulatory and medical affairs

Q: In which countries can MultiHealth Group submit an application for clinical trial authorization?

MultiHealth Group has the capability to submit claims in France, Germany, Italy, Spain, Switzerland, the United Kingdom, Belgium, Poland, Portugal, the Netherlands, Greece, Austria, the Czech Republic, Canada, and the United States.

Home » Areas of Expertise » Regulatory Affairs

Get a quote

What is regulatory affairs in clinical research?

Our Regulatory and Medical Affairs department supports healthcare stakeholders in defining and implementing their regulatory strategies, from clinical development to market launch and throughout the product lifecycle. Our experts assist with regulatory submissions in France and internationally, the drafting and compilation of dossiers, CMC activities, and maintaining regulatory compliance for drugs and medical devices.

Regulatory Management of Clinical Trials

Regulatory Affairs Specialist reviewing a clinical trial submission dossier

Regulatory Consulting and Strategy: Defining a regulatory strategy tailored to the product, the type of study, and the countries involved, while taking into account European and local requirements.

Preparation and Submission of Applications: Preparation, review, and submission of clinical trial authorization applications to the relevant authorities and ethics committees: initial submissions, substantial amendments, responses to requests for information, and follow-up until authorization is granted.

Regulatory Management Throughout the Study: Monitoring regulatory requirements throughout the duration of the trial, including amendments, notifications, document updates, and regulatory closure.

International Regulatory Expertise

We assist sponsors with their clinical trial submissions in France and internationally, drawing on our expertise in European procedures and the regulatory requirements specific to each country.

Experts preparing regulatory submissions for clinical trials in several European countries

European Submissions – Pharmaceuticals: Preparation, coordination, and follow-up of applications for clinical trial authorization via CTIS, in accordance with applicable European regulations.

Clinical Investigations – Medical Devices: Support for clinical investigations and performance studies in accordance with the MDR and IVDR, including management of interactions with competent authorities and ethics committees in accordance with national procedures.

International coverage: Ability to submit bids in France, Germany, Italy, Spain, Switzerland, the United Kingdom, Belgium, Poland, Portugal, the Netherlands, Greece, Austria, the Czech Republic, Canada, and the United States.

Drafting & Regulatory Documentation

Our experts assist manufacturers in drafting, compiling, reviewing, and updating their regulatory documentation—from clinical development through market authorization and throughout the product's lifecycle.

Medical writer working on regulatory documentation for a drug

Regulatory Documentation – Pharmaceuticals: Drafting and reviewing documents required for regulatory submissions and clinical development, including protocols, Investigator’s Brochures (IB), IMPDs, amendments, and responses to regulatory authorities.

Technical Documentation – Medical Devices: Preparation and updating of the technical documentation required for CE marking, in accordance with the requirements of the MDR and the IVDR.

Regulatory monitoring of the product: Assistance with updating and maintaining compliance with regulatory documentation requirements, including CER, PMS, PMCF, PSUR, and other applicable regulatory documents.

Regulatory support throughout the entire lifecycle

Our experts will guide you through the process of defining and refining your regulatory strategy, from the earliest stages of development through to maintaining compliance after the product is launched.

A team of regulatory experts planning the stages of a healthcare product's lifecycle

Regulatory Consulting and Strategy: Analysis of applicable requirements, gap analysis, definition of development strategies, and preparation for interactions with health authorities.

Interactions with Authorities: Preparing for communications and meetings with the relevant authorities, providing support for requests for guidance, and managing regulatory issues.

Lifecycle management: Management of changes, variations, renewals, and regulatory updates to ensure product compliance throughout its lifecycle.

Ensuring the security of your research and maximizing the value of your data for the greatest possible scientific impact

Download the brochure

Compliance & Security

Our services comply with the most stringent regulatory frameworks governing health data.

Your clinical data is hosted exclusively by providers certified as Health Data Hosts (HDS), in accordance with the requirements of the ANS and Article L.1111-8 of the Public Health Code.

Your personal data is processed in accordance with the GDPR and the CNIL's best practices.

Frequently Asked Questions

What is the CTIS, and why is it mandatory for clinical trials of drugs in Europe?

The CTIS (Clinical Trials Information System) is the single European platform through which all applications for authorization of clinical trials of medicinal products in the European Union are processed, pursuant to Regulation (EU) No. 536/2014.

What is the difference between a regulatory submission for a drug and one for a medical device?

Drugs are governed by the CTIS and the European Clinical Trials Regulation, while medical devices must comply with the requirements of the MDR and the IVDR, along with specific national procedures involving the competent authorities and ethics committees.

In which countries can MultiHealth Group submit an application for clinical trial authorization?

MultiHealth Group has the capacity to submit claims in France, Germany, Italy, Spain, Switzerland, the United Kingdom, Belgium, Poland, Portugal, the Netherlands, Greece, Austria, the Czech Republic, Canada, and the United States.

What is an IMPD, and when is it required?

The IMPD (Investigational Medicinal Product Dossier) is the regulatory dossier describing the quality, manufacturing, and preclinical/clinical data for an investigational drug. It is required upon the initial submission of a clinical trial through the CTIS.

What are the regulatory requirements after a health product has been placed on the market?

After being placed on the market, a health product remains subject to post-market surveillance requirements: PSURs for drugs, PMS and PMCF for medical devices, as well as the management of variations and marketing authorization renewals.

What is the CE marking for a medical device, and what requirements does it entail?

The CE marking certifies that a medical device complies with the essential safety and performance requirements of the MDR or the IVDR. It requires the preparation of comprehensive technical documentation, which must be kept up to date throughout the product’s lifecycle.

Our teams are at your service

contact@multihealthgroup.com

01 80 13 14 70

Request a presentation

if you would like to talk to an expert