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We are specialized in the management of drug or medical devices development projects from lead identification to launch and beyond. We can handle New Chemical Entities (NCEs), generics, as well as medical devices, biotechnology products and life cycle management projects. We will help you optimizing the development of your product with regards to time and cost while strictly complying with regulatory guidelines and requirements.
We can rely on our extensive experience and long-lasting relationships in the health care business to assist you in identifying, assessing and selecting reliable partners for all steps of your development project.
We can advise you in designing and implementing your development program and maximizing the chances of success. But we can also actively manage part or all of your project (planning organization, selection of suitable development partners, coordination, monitoring and control of the various steps of the development process).
This includes:
Elaboration, planning and implementation of global development strategy
Production of Active Pharmaceutical Ingredient (API) at required scale
Development and production of appropriate formulation to achieve your targets, including, if necessary, selection of the most adapted drug delivery technology
Design, conduct and monitoring of preclinical and clinical studies, including Clinical Trial Applications (CTA) and Ethics Committee submissions (EC)
Conception of global regulatory strategy, based on thorough understanding of guidelines, including contacts and discussions with regulatory authorities
Selection and monitoring of reliable development partners
Obtaining protection of your product by strong intellectual Property (IP)
Seeking expert opinions if necessary
Preparation, control and monitoring of budgets
Preparation of all documents necessary during development (please refer to our medical writing section for more details on this service)
Dossier submission (please refer to our medical writing and regulatory support sections for more details on this service)
We can carry out small start-up projects or large ones, nationally or internationally (mainly in EU and the US) in all therapeutic areas.
If you need support or reliable advice, if you are short of resources, just contact us, we will assist you and provide solutions tailored to your needs and objectives. Together we will reduce time to market of your product.
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