Within our due diligence team, there are a substantial number of senior consultants who have experienced in dealing with all aspects of the due diligence process and requirements to support client projects. This experience has been gained both working on projects at DLRC and from experience at previous companies. The depth of regulatory due diligence expertise offered by our consultants comes from years of experience at large pharma and subsequent work within DLRC.
Small and Medium Enterprise Status (SME)
Organisations with fewer than 250 employees and an annual turnover of not more than €50 million or an annual balance-sheet total of not more than €43 million may qualify for SME status which comes with a range of practical and financial regulatory benefits. DLRC can help you to assess your suitability for the scheme as well as provide guidance on the application process. In addition, if your company meets EU SME criteria but is not established in the EU/EEA, you can still benefit from SME incentives through our EU/EEA-established SME regulatory consultancy, DLRC Pharma Services Ltd based in Ireland. UK companies now need to apply for EU SME status as a result of leaving the EU.
EU Legal Representative
Clinical Trial Applications and Orphan Drug Designation Applications cannot be made in the EU unless the applicant is established in the EU/EEA or appoints an EU legal representative. DLRC Pharma Services Ltd in Ireland can act as the EU legal representative for clients based outside the EU/EEA.