Drug Development Strategy

An integrated approach for pre-clinical and clinical is essential for the development of a drug and the submission of a marketing authorization application. For each drug project, a well-conceived development strategy, focused on the clients’ specific needs, is the indispensable basis of a first- time-right study program. A first-time-right approach results in the timely start of the different drug development steps from early stage to efficient dossier preparation and an uneventful review by regulatory authorities.

By asking LRSS to work out the Regulatory Affairs & Drug Dvelopment strategy for a project, YOU as the client may expect:

• a strategy in compliance with the short-term and long-term project objectives and integrated with chemical, pharmaceutical, pre-clinical clinical and regulatory strategies

• a strategy tailored to existing data and the applicable regulatory guidelines

• clear rationales and objectives for the studies envisaged

• a development plan allowing to proceed to a satisfactory planning, an accurate budget and a successful control of the potential constraints