IBB Consulting ApS

IBB Consulting supports players in the pharmaceutical drug development arena with regard to design and outsourcing of non-clinical safety programs in the context of regulatory guideline requirements, as well as the interpretation of toxicology data and generation of regulatory submission documents during all phases from early development to marketing. Together with you, IBB Consulting will develop non-clinical plans and find solutions when you meet challenges, have limited human resources or experience within non-clinical development, or when you just need a second opinion. Your benefits will be clear decision-making and confidence in your next steps of your drug development program. Advice and core services provided: • Non-clinical development plans for all stages prior to First Human Dose to marketing application according to regulatory requirements • Outsourcing and monitoring of non-clinical safety studies at professional CROs • Interpretation of toxicology data • Writing of non-clinical sections for regulatory submission documents • Scientific input to response letters to regulatory health authorities More specific: • Species qualification strategy for safety studies • In vitro and in vivo non-clinical safety models • General toxicology studies • Reproductive, developmental and juvenile toxicology studies • Paediatric plans (PIPs) - non-clinical parts • Detailed study design, outsourcing, monitoring and report finalisation • Data review and interpretation • Identification, assessment and mitigation of potential safety risks • Investigative toxicology and mechanistic problem solving • Preparation for scientific advisory meetings and regulatory interactions • Preparation of the nonclinical sections for INDs/CTAs/NDAs/BLAs, etc • Support to due diligences • Facilitation of scientific collaboration across industry and academia • Preparation of scientific publications and position papers • Educational sessions within non-clinical safety, toxicology and safety pharmacology For more information please visit http://www.ibbconsulting.dk/ Contact: in@ibbconsulting.dk