Development
Our expert DLRC consultants have the skills needed to effectively guide you through product development. They can support you from your pre-clinical study design all the way to successful marketing authorisation.
We use our flexible and creative approach, combined with our deep understanding of the global regulatory environment, to help our clients navigate and optimise their development seamlessly. This maximises the chance of success for new medicines.
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 to support the first human dose. We also successfully conducted MHRA Innovation Office and Scientific Advice meetings to discuss quality, non-clinical, and clinical plans. DLRC also authored all core regulatory documents, including the Investigational New Drug Application, Investigational New Drug Brochure, Investigational New Drug 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 also other products.
An organisation with no experience of the EU regulatory environment. They already have a product in phase 3 development.
DLRC performed a full gap analysis of the quality of the non-clinical and clinical packages. This, therefore, led to a successful CHMP Scientific Advice interaction. DLRC also advised on the potential for PRIME and orphan designation. DLRC also led the strategy, authoring and negotiation of the EU paediatric investigation plan (PIP). In addition, DLRC supported the generation of clinical trial documents and oversaw CRO regulatory activities on clinical trials conducted in the EU.
Based on advice received, the client conducted additional studies to support registration in the EU. They 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 also on 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. Regulators discussed the key issues 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 also led a parallel EMA/FDA Scientific Advice procedure. The guidance delivered clarified the major aspects of the development program. This, therefore, allowed the development of global clinical studies. 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.
