Cello Health is organised around three core capabilities - Insight, Consulting and Communications - which allows us to look at complex market challenges through ‘multiple lenses’. This enables us to help healthcare businesses unlock the potential of their assets, brands and organisations in a changing and challenging environment. The formation of Cello Health reflects industry pressure to optimise the potential of molecular assets and demonstrate value, recognises the loss of blockbusters, and the subsequent impact on available resources to bring brands to market. The Cello Health structure gives us a broader view of commercial and clinical success and enables us to provide a greater depth and breadth of services to help support your critical decision making.
ERA is able to contribute at any stage of product development, from discovery, through process development, non-clinical and clinical aspects, to regulatory approval and beyond. One of our recognised specialities is the design of a regulatory strategy, to cover part or all of the development process. Thus, our services include the following: Regulatory due diligence exercises for in- or out-licensing, interactions with regulatory agencies, such as pre-IND, pre-BLA and scientific advice procedures, clinical trial applications, marketing authorisation applications, including eCTD submissions, post-approval amendments or variations, advice on process development, including validation, input on characterisation and control, consulting on non-clinical and clinical strategy, facility inspections and support for establishment licensing.
Strategic pharmaceutical and pre-clinical consulting services. Critical due diligence, rationalisation and evaluation of IP portfolios, academic research and early-stage/preclinical projects - ultimately looking to de-risk and increase commercial attractiveness and licensing potential.
Advising and supporting academic institutions and start-up companies on out-sourcing strategies - looking for cost-effective solutions and accelerating the speed of progression and completion of projects.
Oversight and management of outsourced CMC and preclinical projects.
Undertaking due diligences on behalf of organisations in- and out-licencing development drug candidates.
Exploring innovative business models and opportunities for funding between academia and the out-sourcing network, looking to create collaborative win-win partnerships to progress projects.
Attending conferences and exhibitions on behalf of clients, evaluating new product opportunities and service providers.