Representative Services

Access SME Benefits

SMEs based outside the EU cannot directly access the European Medicines Agency’s benefits. However, as a regulatory consultancy, DLRC can provide a link for non-EU based SMEs allowing them to access the EMA benefits.

Orphix Consulting GmbH is an SME designated company and is able to access SME incentives on behalf of SME qualifying companies that are not currently established in the European Union (EU). This can include a 90% reduction in fees for CHMP scientific advice and a delay in the requirement to pay MAA fees until after approval.

We have a dedicated regulatory group with a long and successful track record of partnering with SMEs and that understands their specific needs and challenges. Our expertise and support include:

• Providing EU regulatory strategy and procedural advice from the initial designation to the marketing authorisation
• Advice on the criteria for SME designation
• Preparation, review and submission of documents for SME designation applications
• Representation and holding of the designation on behalf of non-EU clients.

Orphan Drugs

European Orphan Drug Designations must be held by a legal entity based in the EU. Many small biotech’s or start-ups may not have a presence in Europe but want to secure an ODD for their product(s) in development.

DLRC is experienced in acting as the applicant and Orphan Drug Designation Holder on behalf of companies without an EU presence. The DLRC Group has been supporting Orphan drug programs from early development to MAA and post-approval since 2002.

By acting as your Orphan Drug Designation Applicant in the EU, we offer:

• Access to our expertise in securing your Orphan status
• A cost-effective solution to obtaining your ODD without the need to establish a costly EU legal entity
• Advice on the criteria for orphan drug designation in EU
• Preparation and submission of documents for orphan drug designation applications
• Full support from the initial designation to the marketing authorisation, including orphan maintenance.

Sponsors who apply for an Orphan Drug Designation in the US must have a legal entity or presence in the US.  If they do not, a US Agent is necessary to file an application and acts as the liason for communicating with FDA.  DLRC can act as the US Agent for an ODD filing.

Clinical Trials - Legal Representative

The EU Clinical Trials Regulation requires that the Sponsor, or their appointed representative, is legally established within the European Economic Area (EEA). For sponsors based outside the EU, Orphix Consulting GmbH can act as the Legal Representative for your Clinical Trials conducted in the EU or UK.

We are experienced in acting as an EU & UK Legal Representative. We are able to advise on EU clinical trial requirements and provide oversight to ensure your study is authorised and conducted in accordance with EU and UK legislation.

• Separating the Legal Representative and CRO roles allows independent regulatory oversight and continuity in the event of a change in CRO during the study
• Obtain independent expert advice on potential regulatory issues with the proposed study design or set-up
• A clear cost structure incorporating a fixed set-up cost to conduct a risk assessment of the trial, and a monthly fee covering oversight of ongoing activities
• Avoid set up and on-going costs of establishing and maintaining an EU legal entity

Marketing Authorisation

The Marketing Authorisation applicant/holder must be a legal entity established in the EU. Orphix Consulting GmbH can act as the Marketing Authorisation applicant/holder for non-EU based sponsors.

We have experience of successfully managing national, decentralised, mutual recognition and centralised procedures. Orphix Consulting GmbH has the systems and processes in place to take on the role of Applicant quickly and effectively.

• An interim solution – perfect for non-EU sponsors seeking to out-licence rights to a partner company without delaying gaining EU regulatory approvals
• Avoid the need to set up and maintain an EU legal entity (including complying with PV requirements) when following an out-licence model
• Facilitate obtaining MAs in additional markets that may be required to implement commercial strategies
• A straightforward fee structure

US Representation

Sponsors are required to have a representative based in the US for a variety of applications and interactions with the FDA. A US Agent or Representative is required for investigational drug or device applications, requests for formal meetings with the FDA, applications for special designations and marketing applications. The Agent is required to be a US based company or a US citizen.

DLRC Inc., a DLRC Group Company, can act as the US Agent and provide the appropriate representation for sponsors based anywhere in the world, including in the US.  The US Agent would be the correspondent of record for non-US based sponsors.

We have experience successfully filing a variety of applications and notices for clients and we have the capability to rapidly assume the role of US Agent for new and in-process applications. Our experience covers:

• Investigational applications (IND and IDE) for drugs, biologics, devices and combination products.
• Requests for programs and designations that afford a sponsor opportunities to interact with the Agency or obtain other benefits, such as Breakthrough Drug, Breakthrough Device, Fast Track, Orphan Designation, and 513g Request for Designation
• Requests for Formal meetings with the Agency, including Type A, Type B, Type B (End of Phase), Type C, and Pre-Submission meetings
• Request for marketing authorization for drugs (NDA, BLA, or ANDA) and for devices (PMA, de novo 510k or 510k)

A simple monthly fee structure allows a client to utilise DLRC Inc. as their representative in the US as a standalone service or in conjunction with our broader Regulatory Strategy and Operational consulting services.