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A forward thinking regulatory affairs consultancy, DLRC Ltd takes the time to understand individual needs and find creative solutions for any regulatory challenge. From scientific advice in early development, to clinical trials, marketing authorisation applications and post-licensing activities, our highly experienced team helps maximise value through life-cycle management.
Covid-19 and Business Continuity
As a result of the COVID-19 pandemic, we have implemented our Business Continuity Plan with all our employees now working remotely from home. Our office in Letchworth is closed, but we are periodically checking for incoming physical correspondence. Our consultants are contactable via the usual means (email and mobile/landline phone) and we continue to offer our full range of regulatory support services including eCTD submissions.
Please contact email@example.com if you require any further information.
Important news for SME companies:
If your company meets SME criteria but is not established in the EU/EEA, you can still access SME incentives through an EU/EEA-established SME regulatory consultancy. This will apply to UK companies after Brexit so DLRC offers this service via DLRC Pharma Services Ltd, Ireland. SME benefits and incentives include reduction or deferral of fees for a number of procedures such as scientific advice, together with additional direct assistance including the provision of a translation services during Marketing Authorisation Application. Contact us for more details.
DLRC aims to offer renowned and innovative regulatory affairs solutions for the advancement of global healthcare
En tant qu’entreprise de conseil en affaires règlementaires tournée vers l’avenir, DLRC prend le temps de comprendre les besoins individuels de chaque client et d’y répondre par des solutions pour tous les différents défis règlementaire. Notre équipe de professionnels expérimentés vous aide dans l’exploitation et l’optimisation de la valeur ajoutée de votre produit à travers la gestion de son cycle de vie et dans une large gamme d’activités allant de l’avis scientifique durant les étapes initiales du développement, en passant par les essais cliniques, la demande d’Autorisation de Mise sur le Marché jusqu’aux activités post-validation.
“…credit also goes to the regulatory team who have strategised and presented the case to MHRA in a superb and very professional manner. To Carl who worked very hard to provide all supporting data needed and to present it in a way which was convincing and compelling. This was by no means an easy task…”
"I would like to thank you for leading the Article 45 preparation and cross functional review of the Clinical Overview and compilation of the actual submission for submission to EMA and MPA.
I really appreciated you doing this with limited input from my side."
Global Regulatory Group Leader for Established Products for a blue chip pharmaceutical company.
"You did a first class job. Thank you for resolving all the difficult issues so quickly and professionally. It has been very rewarding to work with you because you easily pick up on complicated issues and take responsibility."
Regulatory Director on submission of a MAA for a vaccine.
"You make these difficult things possible and you give me the impression that you never have problems, only solutions."
Regulatory Manager on the submission of a CTD formatted dossier in the UK and Ireland