regulatory-affairs-icta

Regulatory affairs

To help you successfully navigate regulatory hurdles.

Always up to date on the latest regulations in force, we will help you navigate the regulatory landscape, identify the hurdles and define the appropriate strategy to follow.

UNDERSTANDING THE GLOBAL REGULATORY LANDSCAPE IS CRITICAL
TO THE SUCCESS OF YOUR CLINICAL PROGRAMME

Our team in charge of regulatory affairs and submissions to authorities, is composed of experienced experts, who can guide you through the intricate area of regulatory issues and approval timeframes. They will also provide you with all the options to help you choose the best strategy

ICTA Regulatory affairs

OUR MOTTO: A CONSTANT REGULATORY WATCH

We bring you insight on the latest regulations governing drugs, biological products, gene/cell therapies or medical devices at any stage of their clinical development. Combined with our operational expertise, we ensure that your clinical trial is aligned with the latest regulatory agency requirements.

OUR SERVICES INCLUDE

ICTA Regulatory affairs

Regulatory strategy support and guidance to optimise your project start-up

ICTA Regulatory affairs

Consulting and advice on national legislations and specific requirements

ICTA Regulatory affairs

Medical writing support (Protocol, PUT-RD, Informed Consent Form, Case Report Form, etc…)

ICTA Regulatory affairs

Core study documents translation and adaptation to local regulatory requirements

ICTA Regulatory affairs

Compilation of clinical study authorisation application dossier and submission according to local/ European regulations

ICTA Regulatory affairs

Compliance with GDPR and assessment of data privacy compliance

ICTA Regulatory affairs

Responses to requests for information from regulatory bodies

ICTA Regulatory affairs

Management of site contracts

ICTA Regulatory affairs

Regulatory submission of SUSARs and DSURs

ICTA Regulatory affairs

Electronic submission to EudraVigilance

ICTA Regulatory affairs

Expedited reporting to the national Competent Authorities and Ethics Committees according to European regulations

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With local partners who keep on top of the changing regulatory environment across Europe, we provide crucial links to major regulatory authorities and are skilled in the preparation, coordination, and management of complex multinational submissions.

Please note that the new European regulation EU 536/2014 EU53/2014 on clinical trials on medicinal products for human use in Europe is now applicable to all projects that have started and that will end after 31 January 2025. Our teams in charge of regulatory submissions have all been trained to this new regulation.

Other services

Design

Design

A close collaboration of scientific writers and biostatisticians to design your research project and communicate…

Regulatory affairs

Regulatory affairs

To help you successfully navigate regulatory hurdles. Always up to date on the latest regulations…

Project management

Project management

A strong and centralised project management organisation supported by a robust IT platform. Centralised at…

Site Support

Site Support

Do you need experienced Clinical Research Assistants to assist you? Our Clinical Research Assistants /…

Risk-based monitoring

Risk-based monitoring

An agile approach to improve data quality, ensure study continuity and reduce site burden. We…

Vigilance

Vigilance

A wide range of safety services for your clinical research projects

Data management

Data management

Our Data Management team’s motto can be summed up in 5 words: QUALITY, DATA INTEGRITY,…

Biostatistics

Biostatistics

ICTA biometry services to generate high-quality and reliable data for informed decision making. Benefit from…

Medical writing

Medical writing

ICTA offers a range of flexible medical writing solutions to support your clinical program needs…

RGPD compliant
21 CFR Part 11 compliance
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bureau veritas certification icta
bureau veritas certification icta