Product Life Cycle
New information relevant to a product benefit-risk relationship may be identified at any point in the product life cycle.
The nature of the information and its implications differ accordingly. We help clients assess the potential impact of findings on product development and regulatory strategy and to determine what actions should be considered.
PRODUCT LIFE CYCLE
- Pre Clinical
– assess the relevance of in-vitro and in-vivo findings for human risks. Identify the implications for planned and ongoing clinical programs. Guide communication, assessment and risk mitigation strategy
– development of internal safety assessment processes, creation and management of DSMBs, identification, evaluation of unanticipated problems, clinical hold situations. SUSAR management, DSURs, CSRs
- Pre Approval
– Ensure an integrated approach to clinical safety and benefit risk sections of the CTD, strategic approaches to the ISS and the EU Risk Management Plan, REMS negotiation, post approval commitments and PASS studies, pediatric Investigation Plans
- Post- Approval
– Signal identification and management, data-mining strategies, evaluation of new safety findings in the post approval setting, drug utilization studies, evaluation of off label use
- Label and line extension
s – Leverage existing evidence to facilitate label and line extensions
- Generics – evaluate the implications to product benefit-risk resulting from findings from comparable or interchangeable products
OTC – Decision making with regard to moving products to OTC. Benefit risk implications of availability of other products on OTC including the potential for interaction