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Regulatory Strategy

Science-based, global product development
  • Leveraging existing regulatory science, across geographical regions, to accelerate novel technologies
  • Developing customized regulatory strategies through Requests for Designation (RFD), INTERACT and preIND meeting packages
  • Preparation of CMC document risk assessments, CTD documents, application reviews and consultation

Regulatory Data

Patient, investor, regulator friendly source document preparation
  • Preparing manufacturing and preclinical reports that can be used for clinical trial protocol development, investor-grant agency review and regulatory submissions
  • Identifying niche scientists to provide or validate expert justifications for manufacturing, product control / analytical testing, and stability

Regulatory Knowledge

Avoid redundant investments through leverage of academic, industry and regulatory global databases
  • Assembly of technology targeted data packages for clinical trials (global clinical trial databases)
  • Assembly of chemistry, manufacturing and control (CMC) information for Gene Therapy, Cellular Therapy, Vaccine and Biologic Summary Basis of Approvals (FDA)
  • European Public Assessment Reports (EU), regulatory Advisory Committee meeting minutes and related public consultations
  • PubMed searches and client database creation with preferred publication management software (EndNote, Reference Manager, Etc)