Services

Drug safety services

I.D.D.A. Pharma Consulting …..

    • help companies integrating reprotoxicity and genotoxicity data into appropriate contraception requirements in clinical trials for adults and pediatric population as well as integrate this information into the core data sheet and other labeling documents
    • guides the compound selection and implementation of prospective suicidality assessments in clinical trial protocols meeting FDA requirements

Drug development services

I.D.D.A. Pharma Consulting …..

    • offers Global Project Medical Director level support for compounds in development in CNS
    • serves as external resource for companies in preparation of clinical trial protocols, amendment preparation, IB compilation etc
    • conducts external reviews of clinical documents like protocols and amendments
    • gives guidance and assistance in crafting answers to questions from health authorities, as well as preparation of briefing books and submissions to health authorities
    • assists and leads the preparation and maintenance of Core Data Sheets and product local labels

Mentoring & Coaching

I.D.D.A. Pharma Consulting

    • coaching/mentoring newcomers to industry from academia, individual coaching on day to day challenges
    • support on cross-cultural challenges, strategies and tactics to turn them into a win-win situations