Medical Device Development

  • Product design and development from concept stage through testing, verification and validation, and scale-up
  • Defining user needs and human factors considerations
  • Implementation of concurrent engineering to ensure designs are manufacturable
  • Risk analysis and mitigation strategies
  • Manufacturing and process development, from early stage for clinical trials, through scale up
  • Development of efficient Quality systems for device development (QSR), including Design Control
  • Development of strategy for least burdensome approach for regulatory approval of the product
  • Generation and review of regulatory documents, including Briefing Packages for Agency meetings, IDE, 510k and PMA submissions. Support on regulatory compliance
  • Support on development and implementation of IP strategy

Drug Delivery and Combination Medical Products

  • Definition of unmet medical need
  • Product design and development, including pre-clinical formulation and testing, through clinical evaluation and scale-up
  • Risk analysis and mitigation strategies
  • Manufacturing and process development, from early stage for clinical trials, through scale up
  • Development of efficient Quality systems for both drug (cGMP) and combination product (QSR / Design Control) development
  • Development of strategy for least burdensome approach for regulatory approval of the product
  • Generation and review of regulatory documents, including Briefing Packages for Agency meetings, IND, NDA and ANDA submissions. Support on regulatory compliance (CMC)
  • Support on development and implementation of IP strategy

Technical Assessment / Due Diligence

  • Detailed evaluation of concepts / proposals for technical soundness and feasibility, and identification of key risk areas
  • Conducting technical due diligence on products or technology platform

Product Development Planning / Project Management

  • Project Management involving efficient interactions between the various functional areas that are involved in the development process (Design/Formulation, Non-clinical, Clinical, QA/QC, Marketing, Manufacturing, Regulatory, Facilities, Finance/Budgeting, Intellectual Property) to effect a successful outcome for the development process that is on-time and on-budget