Your legal representative
Why act as legal representative ?
As a European representative, BluePharm legally represents manufacturers/sponsors located outside the European Union for the conduct of clinical trials and clinical investigations in the EU.
This essential role ensures regulatory compliance and legal accountability for studies conducted in accordance with Regulations (EU) 536/2014 and (EU) 2017/745, guaranteeing the safety of participants and the reliability of data.
Full regulatory and legal responsibility
BluePharm acts as the official liaison with the competent authorities and assumes legal responsibility for studies conducted in the European Union.
Our teams ensure that the sponsor complies with all regulatory requirements, from initial submission to study completion.
Our role includes:
- Legal representation of sponsors not established in the EU.
Communication with authorities (ANSM, EMA, Ethics Committees).
Monitoring compliance with European regulations.
Document management and regulatory traceability.
Effective interface with the authorities
As the sole point of contact between the sponsor and the European authorities, BluePharm facilitates communication and ensures responsiveness throughout the regulatory process.
We ensure smooth coordination with national and European authorities, for harmonised and compliant submissions in each country concerned.
Expertise based on rigor and trust
With its extensive experience in clinical research and strong European presence, BluePharm offers an approach that is expert, agile and secure.
Our specialists are fully proficient in the requirements of the European Clinical Trials Regulation (EU 536/2014) and the Medical Devices Regulation (EU 2017/745), not to mention IA ACT, ensuring compliant and flawless representation.
Why choose BluePharm as your European representative?
Proximity and availability: a French-speaking team based in Europe, in direct contact with the authorities.
Recognised regulatory expertise: mastery of EMA, ANSM and Ethics Committee frameworks.
Quality commitment: full compliance, traceability and transparency.
Global partner: support available for vigilance, documentation, and regulatory training
A flexible subscription-based offer
In order to meet the recurring needs of international developers, BluePharm proposes an annual subscription model:
A simple and transparent option, adapted to the number of studies conducted in the EU.
Ongoing support including regulatory monitoring, compliance tracking and documentary support.
Guaranteed responsiveness for all interactions with the relevant authorities.
This subscription-based approach allows promoters to access a permanent European representative service without administrative constraints or unpredictable costs.
