Legal Representative Services for Life Sciences
PharMarketing provides legal representation services for pharmaceutical, biotech, medical device and clinical research organisations operating in the European Union and the United Kingdom. We support non-EU and non-UK organisations that need an established representative for clinical trials, GDPR compliance, UK GDPR compliance, EU orphan designation applications and SME-related regulatory procedures.
Our services are designed for international life sciences organisations that need practical, responsive local representation while entering or operating in regulated European markets.
Our Legal Representation Services
EU Legal Representative for Clinical Trials
If your organisation is established outside the EU/EEA and plans to sponsor a clinical trial in an EU Member State, you may need to appoint an EU/EEA-based legal representative.
PharMarketing provides EU legal representation for clinical trials involving medicinal products, medical devices and other health-related products. Our team supports non-EU sponsors with an established European point of contact for regulatory authorities, ethics committees, research sites and other relevant stakeholders.
Our clinical trial legal representative services include:
- EU/EEA-based legal representation for non-EU clinical trial sponsors
- Support for multinational clinical trial activities
- A local point of contact for regulatory and study-related communications
- Coordination with sponsors, CROs, sites and clinical operations teams
- Practical support informed by GCP, privacy and life sciences compliance requirements
Under the EU Clinical Trials Regulation, non-EU sponsors conducting clinical trials in the EU must have an EU-based legal representative. Communications to that representative are treated as communications to the sponsor.
EU GDPR Representative Services
PharMarketing provides EU GDPR Representative services for organisations established outside the European Economic Area that are subject to the EU GDPR.
An EU GDPR Representative, often called an Article 27 Representative, acts as a contact point for EU data subjects and supervisory authorities regarding your GDPR obligations. This may be relevant when a non-EU organisation offers goods or services to people in the EEA or monitors their behaviour, including in the context of clinical research, digital health, patient-support programmes or other health-data processing.
Our EU GDPR representative services can include:
- Appointment of an EU-based GDPR Representative
- A reliable contact point for data subjects and supervisory authorities
- Support for communications related to GDPR compliance
- Maintenance and availability of required processing documentation, where applicable
- Coordination with your internal privacy, legal, clinical and operational teams
An EU GDPR representative is not the same as a Data Protection Officer. The representative acts as a local contact point for certain non-EEA organisations, while a DPO has independent advisory and monitoring responsibilities.
UK GDPR Representative Services
If your organisation is established outside the UK, has no UK branch or other establishment, and offers goods or services to people in the UK or monitors their behaviour, it may need to appoint a UK GDPR Representative.
PharMarketing provides UK GDPR Representative services for international life sciences organisations processing UK personal data, including patient, participant, healthcare professional and employee data.
Our UK representative services include:
- Appointment of a UK-based GDPR Representative
- A UK contact point for the Information Commissioner’s Office and data subjects
- Support for GDPR-related communications and requests
- Coordination with your DPO, privacy team and relevant operational functions
The UK Information Commissioner’s Office states that organisations outside the UK may need a UK representative when they have no UK establishment but offer goods or services to people in the UK or monitor their behaviour, subject to specific exemptions.
EU Representation for Orphan Drug Designation
PharMarketing supports non-European life sciences organisations requiring EU-based representation in connection with orphan medicinal product designation.
The European Medicines Agency manages the EU orphan designation process, and submissions are made through the EMA’s IRIS system. We provide practical support for organisations that need an established European representative as part of their EU market-access and regulatory strategy.
Our service can support:
- EU representation requirements related to orphan designation activities
- Coordination with regulatory, medical and market-access stakeholders
- Support for international biotech companies entering the EU market
- Alignment between regulatory representation and wider European expansion plans
EU Representation for SME-Related Procedures
We also support eligible life sciences organisations that require EU-based representation for EU SME-related regulatory interactions. This service is relevant for international biotech and pharma companies seeking to maintain an effective EU regulatory presence without establishing a full local operating entity.
PharMarketing combines life sciences, clinical research, GDPR and European regulatory expertise. We understand that legal representation is not merely an administrative requirement: it must work effectively alongside clinical operations, quality, data privacy, regulatory affairs and commercial expansion plans.
Our support is tailored for organisations that need an experienced European partner for:
- Clinical trial expansion into the EU
- EU and UK data-protection representation
- Orphan drug and SME-related EU regulatory procedures
- Cross-border privacy, compliance and clinical research activities