Our expert DLRC consultants have the skills needed to effectively guide you through product development, from your pre-clinical study design all the way to successful marketing authorisation.
Take a look at how we have helped some of our clients.
SME with novel vaccine platform primarily targeting therapeutic oncology indications with little precedent and unclear guidelines.
DLRC worked with the client to develop the non-clinical and clinical plans for to support first human dose and to successfully conduct MHRA Innovation Office and Scientific Advice meetings to discuss quality, non-clinical and clinical plans. DLRC also authored all core regulatory documents including the Investigator Brochure, Investigational Medicinal Product Dossier and Clinical Trial Protocol.
First-in-human clinical trial approved with only minor questions from the MHRA and ethics committee enabling the timely start of phase 1. DLRC continues to provide regulatory and medical writing support to the client on this and other products.
Organisation with no experience of the EU regulatory environment and a product already in phase 3 development.
DLRC performed a full gap analysis of the quality, non-clinical and clinical package leading to a successful CHMP Scientific Advice interaction. DLRC also provided advice on the potential for PRIME and orphan designation and led the strategy, authoring and negotiation of the EU paediatric investigation plan (PIP). In addition, DLRC supported the generation of clinical trial documents and over-saw CRO regulatory activities on clinical trials conducted in the EU.
The client conducted additional studies to support registration in the EU based on advice received and gained approval of their PIP in time to support an EU Marketing Authorisation Application. DLRC continues to provide regulatory support to the client on this and other products.
A US biotech’s lead molecule targeted a paediatric disease with no regulatory precedent.
DLRC advised on a global regulatory strategy. Initial objectives were on securing CTA approval for an early study in paediatric patients. The key issues were discussed with regulators in two national HA meetings leading to CTA approvals for the study. Given the lack of regulatory guidelines and the requirement for a single global program, DLRC lead a parallel EMA/FDA Scientific Advice procedure. This delivered clear guidance on the major aspects of the development program allowing global clinical studies to be developed. We then successfully guided the client through the EU PIP procedure.
The clarity provided regarding the regulatory expectations of both EMA and FDA for their main clinical asset helped the company in securing a multi-billion dollar acquisition by a big pharma company.