Representative Services

EU Representative Services

In compliance with the EU pharmaceutical legislation, Sponsors and/or Marketing Authorisation Holders must establish their presence within the EU/EEA for conducting clinical trials, pursuing Orphan Drug Designations (ODD), securing Marketing Authorisations (MA), and receiving Small and Medium Size Enterprise (SME) benefits, including reduced or deferred fees. To facilitate your engagement with the EU regulatory system, DLRC offers a complete suite of EU representative services.

 

Unlocking SME Benefits

SMEs located outside the EU often face barriers to accessing the valuable benefits offered by the European Medicines Agency (EMA). Fortunately, as a regulatory consultancy, DLRC serves as a bridge for non-EU-based SMEs. This enables them to tap into the EMA’s array of benefits.

As a designated SME company, DLRC has the capability to access SME incentives on behalf of qualifying companies not currently established within the EU. These incentives may include significant benefits such as a substantial 90% reduction in fees for Committee for Medicinal Products for Human Use (CHMP) scientific advice and the flexibility of deferring Marketing Authorisation Application (MAA) fees until post-approval.

Our dedicated regulatory team possesses a long history of successful collaboration with SMEs. We therefore deeply understand their specific needs and challenges.

Our expertise and support include:

• In-depth guidance on meeting the criteria for SME designation.
• Meticulous preparation, review, and submission of documents for SME designation applications.
• Representation and maintenance of the designation on behalf of our non-EU clients.

 

EU Legal Representative for Clinical Trials

In compliance with the EU Clinical Trials Regulation (CTR), it is a prerequisite that the Sponsor or their designated representative is legally established within the European Economic Area (EEA). If your organisation is based outside the EU, DLRC can act as your Legal Representative for Clinical Trials (CT) conducted in the EU.

Our extensive experience in representing companies to EU regulatory authorities and government bodies, both nationally and at the EU level, ensures a seamless process. The DLRC expert team stands ready to guide you through EU clinical trial requirements. We can ensure your study’s authorisation and conformance with all applicable EU legislation.

Advantages of utilising our Legal Representative Services:

• Regulatory Continuity: Maintain flexibility in your development process by engaging multiple Contract Research Organisations (CROs) during your study, all while ensuring ongoing communication with regulators.
• Independent Oversight: Our distinct role as Legal Representative separates us from the CRO function, providing impartial oversight and compliance assurance.
• Cost Efficiency: Avoid the complexities and expenses associated with establishing and managing an EU legal entity while benefiting from our expert guidance.
• On-Hand Expertise: Our team is readily available to offer expert advice and support concerning potential regulatory issues in your study design or setup.

 

EudraVigilance Registration

EudraVigilance is a pivotal European pharmacovigilance database, and for Sponsors aiming to conduct clinical trials within the EU, registration in EudraVigilance is a critical prerequisite. This registration process can often be a determining factor in the timely submission of a clinical trial application (CTA).

Sponsors headquartered outside the EU can only initiate EudraVigilance registration after establishing an EU Legal Representative for the intended trial. At DLRC, we specialise in guiding Sponsors through the intricate steps of initial EudraVigilance registration. Our dedicated team remains at your disposal to address any queries and provide ongoing support.

By leveraging our expertise, you’ll gain access to the essential data required for completing your EU CTA application. Furthermore, you’ll have all the necessary elements in place to commence Individual Case Safety Report (ICSR) submissions once your trial is underway.

 

Orphan Drug Designation (ODD) Sponsor

A legal entity based in the EU must hold EU Orphan Drug Designations. Many small biotech companies or startups operating outside Europe aim to secure an Orphan Drug Designation (ODD) for their products, especially in the early development phases. DLRC can serve as your trusted Orphan Drug Designation Sponsor in the EU, bridging the gap and ensuring compliance. DLRC brings a wealth of experience in Orphan applications. We can provide tailored services to facilitate your EU Orphan Designation.

 

Marketing Authorisation

Obtaining Marketing Authorisation in the EU necessitates that the applicant/holder be a legal entity established within the EU. However, DLRC offers a valuable solution for non-EU companies by acting as the Marketing Authorisation applicant/holder. We have a well-established Quality Management System to support the requisite activities. Therefore, our entities can effectively serve as the applicant or holder of marketing authorisations, ensuring full compliance with legal and regulatory requirements.

Our Marketing Authorisation services provide you with:

• Interim Solutions: Ideal for non-EU sponsors looking to out-license rights to a partner company without delaying EU regulatory approvals.
• Simplified Establishment: Avoid the complexities of setting up and maintaining an EU legal entity, including compliance with Pharmacovigilance (PV) requirements when following an out-license model.
• Market Expansion: Facilitate the acquisition of Marketing Authorisations in additional markets to implement your commercial strategies effectively.

 

In addition, DLRC have expertise in navigating the marketing authorisation process and can support you in obtaining drug approval within the EU. Explore our full range of Marketing Authorisation services to discover how we can assist you throughout the process.

We also provide support for maintaining Marketing Authorisation compliance and managing post-approval changes. Explore our wide range of post-approval services to understand how we can assist you further.

 

EudraVigilance Registration

For all companies aiming to secure product licenses within the EU, registration in EudraVigilance, the EU pharmacovigilance database, is imperative. This registration process can often act as a bottleneck when pursuing a Marketing Authorisation (MA). Marketing authorisation holders must promptly enter granted MAs into EudraVigilance within 5 calendar days to fulfil their legal requirements. These records need consistent maintenance throughout the product’s lifecycle.

DLRC specialises in guiding Sponsors through the complex steps of initial EudraVigilance registration, first-time product license entry, and the ongoing maintenance of these records. Our team of experts is dedicated to providing continuous support and addressing any additional queries you may encounter.

UK Representative Services

Access SME Benefits

Unlock the advantages of SME status in the UK with DLRC’s UK Representative Services. Companies registered as SMEs in the UK, whether based locally or overseas, gain access to exclusive fee benefits. Take advantage of our dedicated regulatory group with a proven history of successful collaboration with SMEs.

We understand the specific needs and challenges of SMEs, offering expertise and support that include:

• SME Designation Guidance: Receive expert advice on meeting the criteria for SME designation, ensuring compliance with registration requirements.
• Efficient Documentation Support: Our team assists in the meticulous preparation, review, and submission of documents necessary for SME designation applications.
• Optimising SME Benefits: Gain insights and advice on maximising the benefits available to SMEs, allowing you to make informed decisions that align with your business goals.

 

Clinical Trials – Legal Representative

The UK regulation on clinical trials requires the Sponsor, or their appointed representative, is legally established within the UK or in the European Economic Area (EEA). For sponsors located outside the UK and EU, DLRC has the ability to act as the Legal Representative for your Clinical Trial planned in the UK.

DLRC is well-versed in serving as a UK Legal Representative. We represent companies to the UK regulatory authority MHRA. Our expert team provides invaluable guidance on UK clinical trial requirements. We can ensure your study is authorised and conducted in adherence to all applicable UK legislation.

Benefits of Engaging Our Legal Representative Services:

• Regulatory Continuity: Maintain flexibility in development by engaging multiple Contract Research Organisations (CROs) during the study while ensuring ongoing communication with regulators.
• Independent Oversight: Separate legal representation from the CRO role, providing impartial oversight and adherence to regulatory standards.
• Cost-Efficient Operations: Avoid the complexities and expenses associated with setting up and maintaining a UK or EU legal entity, streamlining your operational costs.
• Expert Advisory Support: Access expert advice to navigate potential regulatory issues in the proposed study design or setup, ensuring compliance and smooth progression.

 

Orphan Drugs Designation Sponsor

In the UK, Orphan Drug Designation (ODD) applications are submitted in parallel with Marketing Authorisation (MA) submissions. These ODDs remain linked to the MA, even in cases of ownership transfer to a new legal entity. This process eliminates the need for a separate ODD Sponsor, with only a suitably located applicant/holder required for these MAs.

Given the distinct nature of the UK ODD process compared to the EU, DLRC offers additional regulatory support and guidance. We assist you in achieving ODD status seamlessly within your MA submission. Explore more about our comprehensive MA services to understand how DLRC can optimise your regulatory journey here.

 

Marketing Authorisation

For UK Marketing Authorisation, the applicant/holder must be a legal entity established in the UK or EU/EEA. DLRC steps in to act as the Marketing Authorisation applicant/holder for companies based outside the UK or EU, providing a seamless solution. With a robust Quality Management System supporting our activities, our entities can act as an applicant or holder of marketing authorisations. DLRC can ensure comprehensive compliance with all legal and regulatory requirements.

Our Marketing Authorisation applicant/holder services cater to your specific needs:

• Interim Solutions: Ideal for non-UK or -EU sponsors looking to out-license rights to a partner company without delaying the acquisition of UK regulatory approvals.
• Simplified Operations: Bypass the need to set up and maintain a UK or EU legal entity. This includes compliance with Pharmacovigilance (PV) requirements, particularly when adopting an out-license model.

 

DLRC excels in navigating the intricacies of the marketing authorisation process and supports you in obtaining drug approval in the UK. Discover more about our comprehensive Marketing Authorisation Application (MAA) services here.

US Representative Services

For international sponsors striving to comply with FDA regulations in the US, securing a US Agent is a crucial step for various activities related to drugs and biologics. DLRC offers comprehensive US Agent services. We therefore act as a seamless communication link between the FDA and foreign sponsors.

Sponsors are mandated to have a representative based in the US for multiple applications and interactions with the FDA. A US Agent or Representative is requisite for

• Investigational drug or device applications
• Requests for formal meetings with the FDA
• Applications for special designations including Orphan drug designations
• Marketing applications.

 

The appointed Agent must be a US-based company or a US citizen. DLRC assumes the role of the US Agent, offering the necessary representation for sponsors worldwide, including those based in the US. The US Agent becomes the correspondent of record for non-US based sponsors. Our extensive experience includes successfully filing various applications and notices for clients. We have the capability to promptly assume the role of US Agent for new and ongoing applications.

Benefits of Leveraging Our US Representative Services:

• Flexible Regulatory Filing Strategy: Tailored support to define and fulfil your US regulatory filing strategy.
• Expert FDA Communication: Proficient experts in communication with the US regulator, FDA.
• Cost-Efficient Operations: Avoid the complexities and expenses of setting up and maintaining a US-based legal entity.
• Regulatory Issue Support: Access expert advice to navigate potential regulatory issues in the US.
• Flexible Fee Structure: A customisable monthly fee structure allows clients to utilise DLRC as their representative in the US. We can do this either as a standalone service or in conjunction with our broader Regulatory Strategy and Operational consulting services.

Medical Device Representative Services

Medical device regulations in the EU, UK and US require nomination of local contact points for the companies wishing to import or place medical devices to these markets. DLRC provides a full range of medical device representative services. We can empower you in achieving your marketing goals within these regions.

By appointing DLRC as your Representative, you gain access to:

• Expert Healthcare Authority Interactions: Benefit from our expertise in navigating interactions with healthcare authorities.
• In-Depth Regulatory Knowledge: Leverage our extensive knowledge of the ever-evolving medical device regulatory landscapes.
• Legal Representation in US, EU, and GB: Gain the advantage of transparent legal representation across the US, EU, and Great Britain.
• Transparent Fee Structure: We provide a clear and transparent fee structure, ensuring predictability in your financial planning.

 

DLRC brings extensive expertise in guiding you through the necessary steps for placing your medical devices in these markets. Explore our Medical Device services here.

 

UK Responsible Person (UKRP) Services

For medical device manufacturers located outside of Great Britain (GB) intending to place their products on the GB market, designating a UK Responsible Person (UKRP) is mandatory. This designated entity is essential for registering devices with the MHRA to ensure compliance with UK Medical Device Regulations.

DLRC is positioned to provide UKRP services, serving as the intermediary and communicator with the MHRA on behalf of the manufacturer. With a wealth of experience, we ensure that medical devices meet rigorous standards and adhere to all necessary requirements. Our commitment extends to ensuring all documentation and certificates are meticulously prepared and in place before placing a device on the market.

 

EU Authorised Representative (EU AR) Services

For medical device manufacturers situated outside of the EU, designating a sole authorised representative (AR) is essential to access the European Market and maintain compliance with EU Medical Device Regulations.

DLRC is strategically positioned to provide legal representation within the EU. We can serve as the intermediary and communicator with EU authorities on behalf of the manufacturer. Drawing from extensive experience, we ensure that medical devices meet the stringent EU standards and requirements. This guarantees all necessary documentation and certificates are in place prior to placing a device on the market.

 

US Agent Services

For establishments located outside of the United States (US) seeking to import their medical devices into the US, designating a US Agent is a mandatory requirement. DLRC is structured to provide specialised US Agent Services, serving as a crucial communication link between the FDA and foreign establishments.